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Trial record 1 of 3 for:    PF-07104091
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A Study to Investigate the Effect of Tablet Formulation and Food on PF-07104091 in Healthy Participants

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ClinicalTrials.gov Identifier: NCT05431153
Recruitment Status : Completed
First Posted : June 24, 2022
Results First Posted : April 8, 2024
Last Update Posted : April 8, 2024
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
This is a single dose crossover pharmacokinetic (pharmacokinetics helps in understanding how the drug is changed and eliminated from the body after a participant takes it) study in healthy participants. The study consists of 5 treatments, and each participant will be randomized to receive 4 of the treatments in separate periods in a specific sequence. Each treatment consists of a single dose of PF-07104091 and the treatments differ by tablet formulation and/or whether the dose is to be given under fasted or fed conditions. Plasma pharmacokinetics of PF-07104091 will be assessed following each dose to determine the effect of tablet formulation and fed condition on the relative bioavailability of PF-07104091.

Condition or disease Intervention/treatment Phase
Healthy Drug: Single dose of PF-07104091 as Tablet Formulation A (Treatment A) Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B) Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C) Drug: Single dose of PF-07104091 as Tablet Formulation D (Treatment D) Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment E) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, open-label, 4-period, 5-treatment, 6-sequence, crossover study.
Masking: None (Open Label)
Masking Description: Open-label Study
Primary Purpose: Basic Science
Official Title: A PHASE 1, RANDOMIZED, OPEN-LABEL, 4-PERIOD, 5-TREATMENT, 6-SEQUENCE, CROSSOVER, SINGLE-DOSE STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE EFFECT OF TABLET FORMULATION AND FOOD ON THE BIOAVAILABILITY OF PF-07104091
Actual Study Start Date : June 10, 2022
Actual Primary Completion Date : October 17, 2022
Actual Study Completion Date : October 17, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: PF-07104091 Sequence 1
Participants randomized to Sequence 1 will receive Treatments A, B, C, and D in Periods 1 through 4, respectively in the form of tablets by mouth.
 Drug: Single dose of PF-07104091 as Tablet Formulation A (Treatment A)
A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.
Other Name: Tablet Formulation A, Fasted

Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B)
A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.
Other Name: Tablet Formulation B, Fasted

Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C)
A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.
Other Name: Tablet Formulation C, Fasted

Drug: Single dose of PF-07104091 as Tablet Formulation D (Treatment D)
A single dose of PF-07104091 as Tablet Formulation D administered under fasting conditions.
Other Name: Tablet Formulation D, Fasted
Experimental: PF-07104091 Sequence 2
Participants randomized to Sequence 2 will receive Treatments B, C, A, and D in Periods 1 through 4, respectively in the form of tablets by mouth.
 Drug: Single dose of PF-07104091 as Tablet Formulation A (Treatment A)
A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.
Other Name: Tablet Formulation A, Fasted

Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B)
A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.
Other Name: Tablet Formulation B, Fasted

Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C)
A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.
Other Name: Tablet Formulation C, Fasted

Drug: Single dose of PF-07104091 as Tablet Formulation D (Treatment D)
A single dose of PF-07104091 as Tablet Formulation D administered under fasting conditions.
Other Name: Tablet Formulation D, Fasted
Experimental: PF-07104091 Sequence 3
Participants randomized to Sequence 3 will receive Treatments C, A, B, and D in Periods 1 through 4, respectively in the form of tablets by mouth.
 Drug: Single dose of PF-07104091 as Tablet Formulation A (Treatment A)
A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.
Other Name: Tablet Formulation A, Fasted

Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B)
A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.
Other Name: Tablet Formulation B, Fasted

Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C)
A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.
Other Name: Tablet Formulation C, Fasted

Drug: Single dose of PF-07104091 as Tablet Formulation D (Treatment D)
A single dose of PF-07104091 as Tablet Formulation D administered under fasting conditions.
Other Name: Tablet Formulation D, Fasted
Experimental: PF-07104091 Sequence 4
Participants randomized to Sequence 4 will receive Treatments A, B, C, and E in Periods 1 through 4, respectively in the form of tablets by mouth.
 Drug: Single dose of PF-07104091 as Tablet Formulation A (Treatment A)
A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.
Other Name: Tablet Formulation A, Fasted

Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B)
A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.
Other Name: Tablet Formulation B, Fasted

Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C)
A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.
Other Name: Tablet Formulation C, Fasted

Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment E)
A single dose of PF-07104091 as Tablet Formulation C administered under fed conditions.
Other Name: Tablet Formulation C, Fed
Experimental: PF-07104091 Sequence 5
Participants randomized to Sequence 5 will receive Treatments B, C, A, and E in Periods 1 through 4, respectively in the form of tablets by mouth.
 Drug: Single dose of PF-07104091 as Tablet Formulation A (Treatment A)
A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.
Other Name: Tablet Formulation A, Fasted

Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B)
A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.
Other Name: Tablet Formulation B, Fasted

Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C)
A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.
Other Name: Tablet Formulation C, Fasted

Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment E)
A single dose of PF-07104091 as Tablet Formulation C administered under fed conditions.
Other Name: Tablet Formulation C, Fed
Experimental: PF-07104091 Sequence 6
Participants randomized to Sequence 6 will receive Treatments C, A, B, and E in Periods 1 through 4, respectively in the form of tablets by mouth.
 Drug: Single dose of PF-07104091 as Tablet Formulation A (Treatment A)
A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.
Other Name: Tablet Formulation A, Fasted

Drug: Single dose of PF-07104091 as Tablet Formulation B (Treatment B)
A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.
Other Name: Tablet Formulation B, Fasted

Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment C)
A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.
Other Name: Tablet Formulation C, Fasted

Drug: Single dose of PF-07104091 as Tablet Formulation C (Treatment E)
A single dose of PF-07104091 as Tablet Formulation C administered under fed conditions.
Other Name: Tablet Formulation C, Fed


Outcome Measures
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Primary Outcome Measures :
  1. Area Under the Plasma-Concentration Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07104091 for Treatment A, B, and C [ Time Frame: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose ]
    AUCinf was calculated as AUClast + (Clast/kel) where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve.

  2. Maximum Observed Plasma Concentration (Cmax) of PF-07104091 for Treatment A, B and C [ Time Frame: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose ]
    Cmax was maximum observed concentration. Cmax was observed directly from data.


Secondary Outcome Measures :
  1. AUCinf of PF-07104091 for Treatment C, D and E [ Time Frame: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose ]
    AUCinf was calculated as AUClast + (Clast/kel) where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve.

  2. Cmax of PF-07104091 for Treatment C, D and E [ Time Frame: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose ]
    Cmax was maximum observed concentration. Cmax was observed directly from data.

  3. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs [ Time Frame: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54) ]
    An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, other important medical events. TEAEs were defined as events that occurred after start of treatment.

  4. Number of Participants With Laboratory Test Abnormalities [ Time Frame: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54) ]
    Clinical hematology parameters included: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes; chemistry parameters included: blood urea nitrogen and creatinine, cystatin C and estimated glomerular filtration rate, glucose (fasting), calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, urinalysis parameters included: local dipstick: potential of hydrogen (pH), glucose, protein, blood, ketones, nitrites, leukocyte esterase. Number of participants with abnormal findings are presented in this outcome measure.

  5. Number of Participants With Clinically Meaningful Findings in Electrocardiogram (ECG) Assessments [ Time Frame: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54) ]
    A 12-lead ECG was performed. Clinically meaningful findings in ECG assessments were based on the investigator's judgment.

  6. Number of Participants With Clinically Meaningful Findings in Vital Signs [ Time Frame: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54) ]
    Vital signs were measured with the participant's arm supported at the level of the heart after approximately 5 minutes of rest. Vital signs parameters included: diastolic and systolic blood pressure, respiratory rate, pulse rate, and temperature. Number of participants with clinically meaningful findings in any vital sign parameter were reported. Clinically meaningful findings were based on the investigator's judgment.

  7. Number of Participants With Clinically Meaningful Findings in Physical Examination Assessments [ Time Frame: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54) ]
    A complete physical examination included at a minimum, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. A brief physical examination included at a minimum, assessments of general appearance, the respiratory and cardiovascular systems, and participant-reported symptoms. Clinically significant findings were defined according to investigator's assessment.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and standard 12 lead ECGs.
  • Body-Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight of >50 kg (110 lb).
  • Written evidence of a personally signed and dated informed consent document (ICD) indicating that the participant has been informed of all pertinent aspects of the study.
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
  • History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAB) or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
  • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to COVID-19 pandemic (eg, contact with positive case, residence, or travel to an area with high incidence) that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
  • A positive urine drug test.
  • History of sensitivity to heparin or heparin induced thrombocytopenia.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05431153


Locations
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United States, Connecticut
New Haven Clinical Research Unit
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] April 21, 2022
Statistical Analysis Plan  [PDF] June 9, 2022

More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05431153    
Other Study ID Numbers: C4161007
First Posted: June 24, 2022    Key Record Dates
Results First Posted: April 8, 2024
Last Update Posted: April 8, 2024
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
PF-07104091
Food-effect
Relative Bioavailability
Pharmacokinetics
Cyclin-Dependent Kinase 2 (CDK2) inhibitor