A Relative Bioavailability Study Evaluating Two New Encorafenib Formulations (ERBA)

• ClinicalTrials.gov Identifier: NCT05446142
• Recruitment Status: Completed
• First Posted: July 6, 2022
• Results First Posted: February 23, 2024
• Last Update Posted: February 23, 2024
• Sponsor: Pfizer
• Collaborators: Ono Pharmaceutical Co. Ltd; Pierre Fabre Laboratories
• Information provided by (Responsible Party): Pfizer

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Healthy
• Interventions: Drug: Encorafenib capsule formulation (CAP); Drug: Encorafenib first formulation; Drug: Encorafenib second formulation; Drug: Rabeprazole tablet
• Enrollment: 18

Participant Flow

Recruitment Details
Pre-assignment Details	A total of 18 participants were enrolled and randomized into 1 of the 6 treatment sequences.

Arm/Group Title	Encorafenib 75 mg eMCC=>75 mg eMCCL=>75 mg CAP=>75 mg eMCC+20 mg Rabeprazole	Encorafenib 75 mg eMCC=>75 mg CAP=>75 mg eMCCL=>75 mg eMCCL+20 mg Rabeprazole	Encorafenib 75 mg eMCCL=>75 mg CAP=>75 mg eMCC=>75 mg eMCC+20 mg Rabeprazole	Encorafenib 75 mg eMCCL=>75 m eMCC=>75 mg CAP=>75 mg eMCCL+20 mg Rabeprazole	Encorafenib 75 mg CAP=>75 mg eMCC=>75 mg eMCCL=>75 mg eMCC+20 mg Rabeprazole	Encorafenib 75 mg CAP=>75 mg eMCCL=>75 mg eMCC=>75 mg eMCCL+20 mg Rabeprazole
Arm/Group Description	Period 1: Participants received a single oral dose of encorafenib 75 mg as eMCC under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose. Period 2: Participants received a single oral dose of encorafenib 75 mg as eMCCL under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose. Period 3: Participants received a single oral dose of encorafenib 75 mg as CAP under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose. Period 4: Participants received rabeprazole 20 mg daily from Day -5 to -1, and a single oral dose of encorafenib 75 mg eMCC on Day 1 under fasted condition, followed by serial PK sampling from Day 1 to Day 3.	Period 1: Participants received a single oral dose of encorafenib 75 mg as eMCC under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose. Period 2: Participants received a single oral dose of encorafenib 75 mg as CAP under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose. Period 3: Participants received a single oral dose of encorafenib 75 mg as eMCCL under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose. Period 4: Participants received rabeprazole 20 mg daily from Day -5 to -1, and a single oral dose of encorafenib 75 mg eMCCL on Day 1 under fasted condition, followed by serial PK sampling from Day 1 to Day 3.	Period 1: Participants received a single oral dose of encorafenib 75 mg as eMCCL under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose. Period 2: Participants received a single oral dose of encorafenib 75 mg as CAP under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose. Period 3: Participants received a single oral dose of encorafenib 75 mg as eMCC under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose. Period 4: Participants received rabeprazole 20 mg daily from Day -5 to -1, and a single oral dose of encorafenib 75 mg eMCC on Day 1 under fasted condition, followed by serial PK sampling from Day 1 to Day 3.	Period 1: Participants received a single oral dose of encorafenib 75 mg as eMCCL under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose. Period 2: Participants received a single oral dose of encorafenib 75 mg as eMCC under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose. Period 3: Participants received a single oral dose of encorafenib 75 mg as CAP under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose. Period 4: Participants received rabeprazole 20 mg daily from Day -5 to -1, and a single oral dose of encorafenib 75 mg eMCCL on Day 1 under fasted condition, followed by serial PK sampling from Day 1 to Day 3.	Period 1: Participants received a single oral dose of encorafenib 75 mg as CAP under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose. Period 2: Participants received a single oral dose of encorafenib 75 mg as eMCC under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose. Period 3: Participants received a single oral dose of encorafenib 75 mg as eMCCL under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose. Period 4: Participants received rabeprazole 20 mg daily from Day -5 to -1, and a single oral dose of encorafenib 75 mg eMCC on Day 1 under fasted condition, followed by serial PK sampling from Day 1 to Day 3.	Period 1: Participants received a single oral dose of encorafenib 75 mg as CAP under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose. Period 2: Participants received a single oral dose of encorafenib 75 mg as eMCCL under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose. Period 3: Participants received a single oral dose of encorafenib 75 mg as eMCC under fasted condition, followed by serial PK sampling from Day 1 to Day 3, and a washout of at least 5 days between successive encorafenib dose. Period 4: Participants received rabeprazole 20 mg daily from Day -5 to -1, and a single oral dose of encorafenib 75 mg eMCCL on Day 1 under fasted condition, followed by serial PK sampling from Day 1 to Day 3.
Period Title: Period 1
Started	3	3	3	3	3	3
Completed	3	3	3	3	3	3
Not Completed	0	0	0	0	0	0
Period Title: Period 2
Started	3	3	3	3	3	3
Completed	2	3	3	3	3	3
Not Completed	1	0	0	0	0	0
Reason Not Completed
Adverse Event	1	0	0	0	0	0
Period Title: Period 3
Started	2	3	3	3	3	3
Completed	2	3	3	3	3	3
Not Completed	0	0	0	0	0	0
Period Title: Period 4
Started	2	3	3	3	3	3
Completed	2	3	3	3	3	3
Not Completed	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title		All Participants
Arm/Group Description		All participants enrolled in this study
Overall Number of Baseline Participants		18
Baseline Analysis Population Description		Baseline analysis population included all enrolled participants.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
Mean (SD)	Number Analyzed	18 participants
		46.5 (15.93)
Age, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	18 participants
18-44 Years		9
45-64 Years		7
>=65 Years		2
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	18 participants
	Female	5 27.8%
	Male	13 72.2%
Race/Ethnicity, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	18 participants
White		7
Black or African American		8
Asian		1
American Indian or Alaska Native		1
Black or African American, White		1
Race/Ethnicity, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	18 participants
Hispanic or Latino		5
Not Hispanic or Latino		13

Outcome Measures

1. Primary Outcome

Title	Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinite Time (AUCinf) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
Description	AUCinf for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were calculated by AUClast + (Clast/kel), where AUClast was the area under the plasma concentration-time profile from time zero to last quantifiable concentration, Clast was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel was first-order elimination rate constant.
Time Frame	Day 1 predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose

Outcome Measure Data

Analysis Population Description

The PK parameter analysis population is defined as all participants randomized and treated who have at least 1 of the encorafenib plasma PK parameters of primary interest in at least 1 treatment period.

Arm/Group Title	75 mg Encorafenib eMCC, Fasted	75mg Encorafenib eMCCL, Fasted	75mg Encorafenib CAP, Fasted	75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted	75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
Arm/Group Description:	Participants received a single oral dose of encorafenib 75 mg eMCC under fasted condition.	Participants received a single oral dose of encorafenib 75 mg eMCCL under fasted condition.	Participants received a single oral dose of encorafenib 75 mg CAP under fasted condition.	Participants received a single oral dose of encorafenib 75 mg eMCC (fasted) following 5 days of rabeprazole 20 mg daily.	Participants received a single oral dose of encorafenib 75 mg eMCCL (fasted) following 5 days of rabeprazole 20 mg daily.
Overall Number of Participants Analyzed	18	17	17	7	9
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: ng*hr/mL
	2895; (44%)	2909; (49%)	2957; (41%)	2825; (35%)	2556; (63%)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	75 mg Encorafenib eMCC, Fasted, 75mg Encorafenib CAP, Fasted
	Comments	Natural log transformed encorafenib AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Reference/Test Ratio
	Estimated Value	95.25
	Confidence Interval	(2-Sided) 90%; 90.82 to 99.90
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	75mg Encorafenib eMCCL, Fasted, 75mg Encorafenib CAP, Fasted
	Comments	Natural log transformed encorafenib AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Reference/Test Ratio
	Estimated Value	96.30
	Confidence Interval	(2-Sided) 90%; 91.71 to 101.12
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	75 mg Encorafenib eMCC, Fasted, 75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted
	Comments	Natural log transformed encorafenib AUCinf was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to eMCC with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to eMCC with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Reference/Test Ratio
	Estimated Value	96.57
	Confidence Interval	(2-Sided) 90%; 82.91 to 112.47
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	75mg Encorafenib eMCCL, Fasted, 75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
	Comments	Natural log transformed encorafenib AUCinf was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to eMCCL with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to eMCCL with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Reference/Test Ratio
	Estimated Value	88.56
	Confidence Interval	(2-Sided) 90%; 82.59 to 94.95
	Estimation Comments	[Not Specified]

2. Primary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
Description	Cmax for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were observed directly from data.
Time Frame	Day 1 predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose

Outcome Measure Data

Analysis Population Description

The PK parameter analysis population is defined as all participants randomized and treated who have at least 1 of the encorafenib plasma PK parameters of primary interest in at least 1 treatment period.

Arm/Group Title	75 mg Encorafenib eMCC, Fasted	75mg Encorafenib eMCCL, Fasted	75mg Encorafenib CAP, Fasted	75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted	75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
Arm/Group Description:	Participants received a single oral dose of encorafenib 75 mg eMCC under fasted condition.	Participants received a single oral dose of encorafenib 75 mg eMCCL under fasted condition.	Participants received a single oral dose of encorafenib 75 mg CAP under fasted condition.	Participants received a single oral dose of encorafenib 75 mg eMCC (fasted) following 5 days of rabeprazole 20 mg daily.	Participants received a single oral dose of encorafenib 75 mg eMCCL (fasted) following 5 days of rabeprazole 20 mg daily.
Overall Number of Participants Analyzed	18	18	17	8	9
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: ng/mL
	898.4; (46%)	778.2; (45%)	845.8; (36%)	686.0; (43%)	631.7; (70%)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	75 mg Encorafenib eMCC, Fasted, 75mg Encorafenib CAP, Fasted
	Comments	Natural log transformed encorafenib Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Reference/Test Ratio
	Estimated Value	104.31
	Confidence Interval	(2-Sided) 90%; 91.40 to 119.04
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	75mg Encorafenib eMCCL, Fasted, 75mg Encorafenib CAP, Fasted
	Comments	Natural log transformed encorafenib Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Reference/Test Ratio
	Estimated Value	90.35
	Confidence Interval	(2-Sided) 90%; 79.17 to 103.12
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	75 mg Encorafenib eMCC, Fasted, 75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted
	Comments	Natural log transformed encorafenib Cmax was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to eMCC with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to eMCC with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Reference/Test Ratio
	Estimated Value	79.66
	Confidence Interval	(2-Sided) 90%; 58.70 to 108.08
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	75mg Encorafenib eMCCL, Fasted, 75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
	Comments	Natural log transformed encorafenib Cmax was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to eMCCL with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to eMCCL with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Reference/Test Ratio
	Estimated Value	80.78
	Confidence Interval	(2-Sided) 90%; 64.82 to 100.68
	Estimation Comments	[Not Specified]

3. Primary Outcome

Title	Area Under the Plasma Concentration-Time Profile From Time Zero to Last Quantifiable Concentration (AUClast) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
Description	AUClast for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were calculated using Linear/Log trapezoidal method.
Time Frame	Day 1 predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose

Outcome Measure Data

Analysis Population Description

The PK parameter analysis population is defined as all participants randomized and treated who have at least 1 of the encorafenib plasma PK parameters of primary interest in at least 1 treatment period.

Arm/Group Title	75 mg Encorafenib eMCC, Fasted	75mg Encorafenib eMCCL, Fasted	75mg Encorafenib CAP, Fasted	75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted	75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
Arm/Group Description:	Participants received a single oral dose of encorafenib 75 mg eMCC under fasted condition.	Participants received a single oral dose of encorafenib 75 mg eMCCL under fasted condition.	Participants received a single oral dose of encorafenib 75 mg CAP under fasted condition.	Participants received a single oral dose of encorafenib 75 mg eMCC (fasted) following 5 days of rabeprazole 20 mg daily.	Participants received a single oral dose of encorafenib 75 mg eMCCL (fasted) following 5 days of rabeprazole 20 mg daily.
Overall Number of Participants Analyzed	18	18	17	8	9
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: ng*hr/mL
	2879; (44%)	2858; (48%)	2934; (41%)	2635; (37%)	2529; (65%)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	75 mg Encorafenib eMCC, Fasted, 75mg Encorafenib CAP, Fasted
	Comments	Natural log transformed encorafenib AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Reference/Test Ratio
	Estimated Value	95.34
	Confidence Interval	(2-Sided) 90%; 90.37 to 100.59
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	75mg Encorafenib eMCCL, Fasted, 75mg Encorafenib CAP, Fasted
	Comments	Natural log transformed encorafenib AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Reference/Test Ratio
	Estimated Value	94.67
	Confidence Interval	(2-Sided) 90%; 89.73 to 99.88
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	75 mg Encorafenib eMCC, Fasted, 75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted
	Comments	Natural log transformed encorafenib AUClast was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to eMCC with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to eMCC with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Reference/Test Ratio
	Estimated Value	95.76
	Confidence Interval	(2-Sided) 90%; 84.10 to 109.04
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	75mg Encorafenib eMCCL, Fasted, 75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
	Comments	Natural log transformed encorafenib AUClast was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to eMCCL with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to eMCCL with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Reference/Test Ratio
	Estimated Value	88.31
	Confidence Interval	(2-Sided) 90%; 82.36 to 94.70
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Time for Cmax (Tmax) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
Description	Tmax for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were observed directly from data as time of first occurrence.
Time Frame	Day 1 predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose

Outcome Measure Data

Analysis Population Description

The PK parameter analysis population is defined as all participants randomized and treated who have at least 1 of the encorafenib plasma PK parameters of primary interest in at least 1 treatment period.

Arm/Group Title	75 mg Encorafenib eMCC, Fasted	75mg Encorafenib eMCCL, Fasted	75mg Encorafenib CAP, Fasted	75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted	75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
Arm/Group Description:	Participants received a single oral dose of encorafenib 75 mg eMCC under fasted condition.	Participants received a single oral dose of encorafenib 75 mg eMCCL under fasted condition.	Participants received a single oral dose of encorafenib 75 mg CAP under fasted condition.	Participants received a single oral dose of encorafenib 75 mg eMCC (fasted) following 5 days of rabeprazole 20 mg daily.	Participants received a single oral dose of encorafenib 75 mg eMCCL (fasted) following 5 days of rabeprazole 20 mg daily.
Overall Number of Participants Analyzed	18	18	17	8	9
Median (Full Range); Unit of Measure: hr
	1.00; (0.500 to 3.00)	1.00; (1.00 to 1.50)	1.5; (1.00 to 3.00)	1.25; (1.00 to 2.52)	1.00; (0.500 to 3.00)

5. Secondary Outcome

Title	Terminal Half-Life (t½) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
Description	t½ for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were calculated by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.
Time Frame	Day 1 predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose

Outcome Measure Data

Analysis Population Description

The PK parameter analysis population is defined as all participants randomized and treated who have at least 1 of the encorafenib plasma PK parameters of primary interest in at least 1 treatment period.

Arm/Group Title	75 mg Encorafenib eMCC, Fasted	75mg Encorafenib eMCCL, Fasted	75mg Encorafenib CAP, Fasted	75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted	75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
Arm/Group Description:	Participants received a single oral dose of encorafenib 75 mg eMCC under fasted condition.	Participants received a single oral dose of encorafenib 75 mg eMCCL under fasted condition.	Participants received a single oral dose of encorafenib 75 mg CAP under fasted condition.	Participants received a single oral dose of encorafenib 75 mg eMCC (fasted) following 5 days of rabeprazole 20 mg daily.	Participants received a single oral dose of encorafenib 75 mg eMCCL (fasted) following 5 days of rabeprazole 20 mg daily.
Overall Number of Participants Analyzed	18	17	17	7	9
Mean (Standard Deviation); Unit of Measure: hour
	4.691 (1.5680)	4.850 (2.0588)	4.730 (1.7416)	4.710 (2.3714)	5.350 (2.0893)

6. Secondary Outcome

Title	Apparent Clearance (CL/F) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
Description	CL/F for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were calculated by Dose/AUCinf after oral dose.
Time Frame	0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose

Outcome Measure Data

Analysis Population Description

The PK parameter analysis population is defined as all participants randomized and treated who have at least 1 of the encorafenib plasma PK parameters of primary interest in at least 1 treatment period.

Arm/Group Title	75 mg Encorafenib eMCC, Fasted	75mg Encorafenib eMCCL, Fasted	75mg Encorafenib CAP, Fasted	75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted	75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
Arm/Group Description:	Participants received a single oral dose of encorafenib 75 mg eMCC under fasted condition.	Participants received a single oral dose of encorafenib 75 mg eMCCL under fasted condition.	Participants received a single oral dose of encorafenib 75 mg CAP under fasted condition.	Participants received a single oral dose of encorafenib 75 mg eMCC (fasted) following 5 days of rabeprazole 20 mg daily.	Participants received a single oral dose of encorafenib 75 mg eMCCL (fasted) following 5 days of rabeprazole 20 mg daily.
Overall Number of Participants Analyzed	18	17	17	7	9
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: L/hr
	25.91; (44%)	25.81; (49%)	25.38; (41%)	26.53; (34%)	29.34; (64%)

7. Secondary Outcome

Title	Apparent Volume of Distribution (Vz/F) Following Single Oral Doses of Encorafenib 75 mg Alone and With Rabeprazole
Description	Vz/F for encorafenib eMCC, eMCCL and CAP formulations (75 mg, single dose administration), and for encorafenib eMCC and eMCCL formulations (75 mg, single dose administration) following 5 days of rabeprazole 20 mg daily were calculated by Dose/(AUCinf * kel) after oral dose.
Time Frame	0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 hours postdose

Outcome Measure Data

Analysis Population Description

The PK parameter analysis population is defined as all participants randomized and treated who have at least 1 of the encorafenib plasma PK parameters of primary interest in at least 1 treatment period.

Arm/Group Title	75 mg Encorafenib eMCC, Fasted	75mg Encorafenib eMCCL, Fasted	75mg Encorafenib CAP, Fasted	75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted	75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
Arm/Group Description:	Participants received a single oral dose of encorafenib 75 mg eMCC under fasted condition.	Participants received a single oral dose of encorafenib 75 mg eMCCL under fasted condition.	Participants received a single oral dose of encorafenib 75 mg CAP under fasted condition.	Participants received a single oral dose of encorafenib 75 mg eMCC (fasted) following 5 days of rabeprazole 20 mg daily.	Participants received a single oral dose of encorafenib 75 mg eMCCL (fasted) following 5 days of rabeprazole 20 mg daily.
Overall Number of Participants Analyzed	18	17	17	7	9
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Liters
	166.1; (46%)	165.1; (49%)	161.7; (46%)	159.3; (29%)	209; (56%)

8. Secondary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description	An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. Any AEs occurring following start of treatment were considered as treatment emergent adverse event (TEAE). Events that occurred during follow-up within the lag time of up to 28 days after the last encorafenib dose were counted as treatment emergent and attributed to the last treatment taken. Events that occurred during the washout period (up to 28 days from the last treatment) between study periods were counted as treatment emergent and attributed to the previous treatment taken.
Time Frame	Baseline up to Day 28 after the last encorafenib dose (the total duration of the study was approximately 60 days from baseline)

Outcome Measure Data

Analysis Population Description

All participants randomly assigned to a treatment sequence and who took at least 1 dose of encorafenib. Participants were analyzed according to the formulation they actually received.

Arm/Group Title	75 mg Encorafenib eMCC, Fasted	75mg Encorafenib eMCCL, Fasted	75mg Encorafenib CAP, Fasted	75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted	75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
Arm/Group Description:	Participants received a single oral dose of encorafenib 75 mg eMCC under fasted condition.	Participants received a single oral dose of encorafenib 75 mg eMCCL under fasted condition.	Participants received a single oral dose of encorafenib 75 mg CAP under fasted condition.	Participants received a single oral dose of encorafenib 75 mg eMCC (fasted) following 5 days of rabeprazole 20 mg daily.	Participants received a single oral dose of encorafenib 75 mg eMCCL (fasted) following 5 days of rabeprazole 20 mg daily.
Overall Number of Participants Analyzed	18	18	17	8	9
Measure Type: Count of Participants; Unit of Measure: Participants
Participants with AEs (All Causalities)	11 61.1%	11 61.1%	8 47.1%	1 12.5%	5 55.6%
Participants with AEs (Treatment related)	11 61.1%	9 50.0%	8 47.1%	1 12.5%	5 55.6%
Participants with SAEs (All Causalities)	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Participants with severe (including fatal) adverse events (All Causalities)	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

9. Secondary Outcome

Title	Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Description	Haematological, clinical chemistry (serum) and urinalysis safety tests were assessed against the criteria specified in the sponsor reporting standards. The assessment did not take into account whether each participants's baseline test result was within or outside the laboratory reference range for the particular laboratory parameter. The baseline measurement for safety laboratory tests for all periods was the predose measurement on Day -1 of Period 1. Only those categories in which at least 1 participant had data were reported.
Time Frame	Baseline, and at early discontinuation or at the discretion of the investigator (the total duration of the study was approximately 60 days from baseline)

Outcome Measure Data

Analysis Population Description

All participants randomly assigned to a treatment sequence and who took at least 1 dose of encorafenib. Participants were analyzed according to the formulation they actually received. Specifically, number of participants analyzed in the table is the total number of participants with at least one observation of the given laboratory test while on study treatment or during lag time.

Arm/Group Title	75 mg Encorafenib eMCC, Fasted	75mg Encorafenib eMCCL, Fasted	75mg Encorafenib CAP, Fasted	75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted	75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
Arm/Group Description:	Participants received a single oral dose of encorafenib 75 mg eMCC under fasted condition.	Participants received a single oral dose of encorafenib 75 mg eMCCL under fasted condition.	Participants received a single oral dose of encorafenib 75 mg CAP under fasted condition.	Participants received a single oral dose of encorafenib 75 mg eMCC (fasted) following 5 days of rabeprazole 20 mg daily.	Participants received a single oral dose of encorafenib 75 mg eMCCL (fasted) following 5 days of rabeprazole 20 mg daily.
Overall Number of Participants Analyzed	0	1	0	8	9
Measure Type: Count of Participants; Unit of Measure: Participants
HEMATOLOGY - Monocytes/Leukocytes (%) > 1.2 x Upper Limit of Normal (ULN)	0	0 0.0%	0	3 37.5%	0 0.0%
CLINICAL CHEMISTRY - Urate (mg/dL) > 1.2x ULN	0	0 0.0%	0	1 12.5%	0 0.0%
URINALYSIS - Urobilinogen (EU) >= 1	0	0 0.0%	0	0 0.0%	1 11.1%

10. Secondary Outcome

Title	Number of Participants Meeting Vital Signs Categorical Criteria
Description	Supine blood pressure (BP) and pulse rate (PR) were measured at times specified. For Periods 1 to 3, the baseline measurement was the predose measurement on Day -1 of each period. For Period 4, the baseline measurement was the predose measurement on Day -1 of Period 3. The reported categories included: systolic blood pressure (SBP)>=90mmHg; change from baseline (CFB) in SBP>=30mmHg; diastolic blood pressure (DBP)<50mmHg; CFB in DBP>=20mmHg; PR<40 beats per minute (bpm) or PR>120bpm. Only those categories in which at least 1 participant had data were provided.
Time Frame	Baseline, 0 and 2 hours postdose in each period, and at early discontinuation (the total duration of the study was approximately 60 days from baseline)

Outcome Measure Data

Analysis Population Description

All participants randomly assigned to a treatment sequence and who took at least 1 dose of encorafenib. Participants were analyzed according to the formulation they actually received.

Arm/Group Title	75 mg Encorafenib eMCC, Fasted	75mg Encorafenib eMCCL, Fasted	75mg Encorafenib CAP, Fasted	75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted	75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
Arm/Group Description:	Participants received a single oral dose of encorafenib 75 mg eMCC under fasted condition.	Participants received a single oral dose of encorafenib 75 mg eMCCL under fasted condition.	Participants received a single oral dose of encorafenib 75 mg CAP under fasted condition.	Participants received a single oral dose of encorafenib 75 mg eMCC (fasted) following 5 days of rabeprazole 20 mg daily.	Participants received a single oral dose of encorafenib 75 mg eMCCL (fasted) following 5 days of rabeprazole 20 mg daily.
Overall Number of Participants Analyzed	18	18	17	8	9
Measure Type: Count of Participants; Unit of Measure: Participants
	1 5.6%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

11. Secondary Outcome

Title	Number of Participnts With Clinically Significant Electrocardiogram (ECG) Abnormalities
Description	Absolute values and changes from baseline in PR, QT, QRS, heart rate and QTcF were summarized by protocol pre-defined categorization criterion. QTcF were derived using Fridericia's heart rate correction formula. For each period, triplicate ECGs were conducted predose on Day 1; all other ECG measurements were single ECGs. The baseline ECG value was the average of the triplicate ECG measurements collected before dose administration on Day 1. Changes from baseline were defined as the change between the postdose ECG measurement and the derived baseline ECG.
Time Frame	Baseline, 0 and 2 hours postdose in each period, and at early discontinuation (the total duration of the study was approximately 60 days from baseline)

Outcome Measure Data

Analysis Population Description

All participants randomly assigned to a treatment sequence and who took at least 1 dose of encorafenib. Participants were analyzed according to the formulation they actually received.

Arm/Group Title	75 mg Encorafenib eMCC, Fasted	75mg Encorafenib eMCCL, Fasted	75mg Encorafenib CAP, Fasted	75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted	75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
Arm/Group Description:	Participants received a single oral dose of encorafenib 75 mg eMCC under fasted condition.	Participants received a single oral dose of encorafenib 75 mg eMCCL under fasted condition.	Participants received a single oral dose of encorafenib 75 mg CAP under fasted condition.	Participants received a single oral dose of encorafenib 75 mg eMCC (fasted) following 5 days of rabeprazole 20 mg daily.	Participants received a single oral dose of encorafenib 75 mg eMCCL (fasted) following 5 days of rabeprazole 20 mg daily.
Overall Number of Participants Analyzed	18	18	17	8	9
Measure Type: Count of Participants; Unit of Measure: Participants
PR INTERVAL (MSEC) value >= 300 msec or %Chg>=25/50%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
QRS COMPLEX (MSEC) Value >=140 msec or %Chg>=50%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
QT INTERVAL (MSEC) Value >=500 msec	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
QTCF (MSEC) 450 msec <= Value < 480 msec or 480 msec <= Value < 500 msec or Value > 500 msec	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
QTCF (MSEC) 30 msec <= Chg < 60 msec or Chg > 60 msec	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

Adverse Events

Time Frame	Baseline up to Day 28 after the last encorafenib dose. The total duration of the study was approximately 60 days from baseline.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	75 mg Encorafenib eMCC, Fasted	75 mg Encorafenib eMCCL, Fasted	75 mg Encorafenib CAP, Fasted	75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted	75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
Arm/Group Description	Participants received a single ora l dose of encorafenib 75 mg eMCC under fasted condition.	Participants received a single oral dose of encorafenib 75 mg eMCCL under fasted condition.	Participants received a single oral dose of encorafenib 75 mg CAP under fasted condition.	Participants received a single oral dose of encorafenib 75 mg eMCC (fasted) following 5 days of rabeprazole 20 mg daily.	Participants received a single oral dose of encorafenib 75 mg eMCCL (fasted) following 5 days of rabeprazole 20 mg daily.
All-Cause Mortality
	75 mg Encorafenib eMCC, Fasted	75 mg Encorafenib eMCCL, Fasted	75 mg Encorafenib CAP, Fasted	75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted	75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/18 (0.00%)	0/18 (0.00%)	0/17 (0.00%)	0/8 (0.00%)	0/9 (0.00%)
Serious Adverse Events
	75 mg Encorafenib eMCC, Fasted	75 mg Encorafenib eMCCL, Fasted	75 mg Encorafenib CAP, Fasted	75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted	75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/18 (0.00%)	0/18 (0.00%)	0/17 (0.00%)	0/8 (0.00%)	0/9 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	75 mg Encorafenib eMCC, Fasted	75 mg Encorafenib eMCCL, Fasted	75 mg Encorafenib CAP, Fasted	75mg Encorafenib eMCC + 20 mg Rabeprazole, Fasted	75mg Encorafenib eMCCL + 20 mg Rabeprazole, Fasted
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	11/18 (61.11%)	11/18 (61.11%)	8/17 (47.06%)	1/8 (12.50%)	5/9 (55.56%)
Ear and labyrinth disorders
Vertigo * 1	1/18 (5.56%)	0/18 (0.00%)	0/17 (0.00%)	0/8 (0.00%)	0/9 (0.00%)
Eye disorders
Eye pain * 1	0/18 (0.00%)	1/18 (5.56%)	0/17 (0.00%)	0/8 (0.00%)	0/9 (0.00%)
Gastrointestinal disorders
Abdominal discomfort * 1	0/18 (0.00%)	1/18 (5.56%)	0/17 (0.00%)	0/8 (0.00%)	0/9 (0.00%)
Change of bowel habit * 1	0/18 (0.00%)	0/18 (0.00%)	1/17 (5.88%)	0/8 (0.00%)	0/9 (0.00%)
Constipation * 1	1/18 (5.56%)	0/18 (0.00%)	0/17 (0.00%)	0/8 (0.00%)	0/9 (0.00%)
Dyspepsia * 1	0/18 (0.00%)	0/18 (0.00%)	0/17 (0.00%)	1/8 (12.50%)	0/9 (0.00%)
Nausea * 1	0/18 (0.00%)	0/18 (0.00%)	1/17 (5.88%)	0/8 (0.00%)	0/9 (0.00%)
Paraesthesia oral * 1	1/18 (5.56%)	1/18 (5.56%)	0/17 (0.00%)	0/8 (0.00%)	1/9 (11.11%)
Vomiting * 1	1/18 (5.56%)	0/18 (0.00%)	0/17 (0.00%)	0/8 (0.00%)	0/9 (0.00%)
Abdominal pain * 1	1/18 (5.56%)	0/18 (0.00%)	0/17 (0.00%)	0/8 (0.00%)	0/9 (0.00%)
General disorders
Chills * 1	1/18 (5.56%)	0/18 (0.00%)	0/17 (0.00%)	0/8 (0.00%)	1/9 (11.11%)
Facial pain * 1	0/18 (0.00%)	0/18 (0.00%)	0/17 (0.00%)	0/8 (0.00%)	1/9 (11.11%)
Fatigue * 1	0/18 (0.00%)	2/18 (11.11%)	0/17 (0.00%)	0/8 (0.00%)	0/9 (0.00%)
Feeling hot * 1	4/18 (22.22%)	4/18 (22.22%)	1/17 (5.88%)	0/8 (0.00%)	0/9 (0.00%)
Vessel puncture site bruise * 1	0/18 (0.00%)	0/18 (0.00%)	1/17 (5.88%)	0/8 (0.00%)	0/9 (0.00%)
Vessel puncture site pain * 1	0/18 (0.00%)	0/18 (0.00%)	1/17 (5.88%)	0/8 (0.00%)	0/9 (0.00%)
Injury, poisoning and procedural complications
Skin abrasion * 1	0/18 (0.00%)	1/18 (5.56%)	0/17 (0.00%)	0/8 (0.00%)	0/9 (0.00%)
Metabolism and nutrition disorders
Decreased appetite * 1	0/18 (0.00%)	0/18 (0.00%)	0/17 (0.00%)	0/8 (0.00%)	1/9 (11.11%)
Musculoskeletal and connective tissue disorders
Back pain * 1	1/18 (5.56%)	0/18 (0.00%)	0/17 (0.00%)	0/8 (0.00%)	0/9 (0.00%)
Nervous system disorders
Dizziness * 1	1/18 (5.56%)	0/18 (0.00%)	0/17 (0.00%)	0/8 (0.00%)	1/9 (11.11%)
Dysaesthesia * 1	0/18 (0.00%)	2/18 (11.11%)	1/17 (5.88%)	0/8 (0.00%)	1/9 (11.11%)
Headache * 1	4/18 (22.22%)	2/18 (11.11%)	5/17 (29.41%)	1/8 (12.50%)	2/9 (22.22%)
Paraesthesia * 1	0/18 (0.00%)	2/18 (11.11%)	0/17 (0.00%)	0/8 (0.00%)	1/9 (11.11%)
Psychiatric disorders
Insomnia * 1	1/18 (5.56%)	0/18 (0.00%)	0/17 (0.00%)	0/8 (0.00%)	0/9 (0.00%)
Skin and subcutaneous tissue disorders
Dermatitis allergic * 1	0/18 (0.00%)	1/18 (5.56%)	0/17 (0.00%)	0/8 (0.00%)	0/9 (0.00%)
Pruritus * 1	0/18 (0.00%)	1/18 (5.56%)	0/17 (0.00%)	0/8 (0.00%)	0/9 (0.00%)
Pseudofolliculitis * 1	0/18 (0.00%)	0/18 (0.00%)	0/17 (0.00%)	0/8 (0.00%)	1/9 (11.11%)
Rash pruritic * 1	1/18 (5.56%)	0/18 (0.00%)	0/17 (0.00%)	0/8 (0.00%)	0/9 (0.00%)
Vascular disorders
Flushing * 1	0/18 (0.00%)	2/18 (11.11%)	0/17 (0.00%)	0/8 (0.00%)	0/9 (0.00%)
Hot flush * 1	0/18 (0.00%)	1/18 (5.56%)	2/17 (11.76%)	0/8 (0.00%)	0/9 (0.00%)
1 Term from vocabulary, MedDRA version 25.0; * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.
• Phone: 1-800-718-1021
• EMail: ClinicalTrials.gov_Inquiries@pfizer.com

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT05446142
• Other Study ID Numbers: C4221024
• First Submitted: July 1, 2022
• First Posted: July 6, 2022
• Results First Submitted: July 24, 2023
• Results First Posted: February 23, 2024
• Last Update Posted: February 23, 2024