A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment

• ClinicalTrials.gov Identifier: NCT00785772
• Recruitment Status: Terminated
• First Posted: November 5, 2008
• Results First Posted: April 27, 2011
• Last Update Posted: February 3, 2021
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Information provided by (Responsible Party): Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Renal Impairment
• Intervention: Drug: Gabapentin
• Enrollment: 1

Participant Flow

Recruitment Details	Study Initiation Date and Completion Dates: 16 March 2010 to 1 April 2010 Study Center: 1 center in Japan
Pre-assignment Details	A subject who had already been taking gabapentin was enrolled in the study.

Arm/Group Title	Gabapentin
Arm/Group Description	The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time. The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days.
Period Title: Overall Study
Started	1
Completed	1
Not Completed	0

Baseline Characteristics

Arm/Group Title		Gabapentin
Arm/Group Description		The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time. The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days.
Overall Number of Baseline Participants		1
Baseline Analysis Population Description		[Not Specified]
Age, Customized; Measure Type: Number; Unit of measure: Participant	Number Analyzed	1 participants
<=19 years		0
20-64 years		1
>=65 years		0
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1 participants
	Female	0 0.0%
	Male	1 100.0%

Outcome Measures

1. Primary Outcome

Title	Observed Plasma Gabapentin Concentration
Description	Plasma gabapentin concentrations were measured on Day 8 and Day 15
Time Frame	Days 8 and 15

Outcome Measure Data

Analysis Population Description

The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.

Arm/Group Title	Gabapentin
Arm/Group Description:	The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time. The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days.
Overall Number of Participants Analyzed	1
Mean (Full Range); Unit of Measure: µg/mL
Day 8	38.40; (38.40 to 38.40)
Day 15	44.64; (44.64 to 44.64)

2. Primary Outcome

Title	Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model
Description	Ratio of observed plasma gabapentin concentration to predicted plasma gabapentin concentration based on population pharmacokinetics model were calculated on Day 8 and Day 15, respectively.
Time Frame	Days 8 and 15

Outcome Measure Data

Analysis Population Description

The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.

Arm/Group Title	Gabapentin
Arm/Group Description:	The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time. The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days.
Overall Number of Participants Analyzed	1
Measure Type: Number; Unit of Measure: Ratio
Day 8	2.16
Day 15	2.59

3. Primary Outcome

Title	Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration
Description	Ratio of observed plasma gabapentin concentration to individual predicted plasma gabapentin concentration were calculated on Day 8 and Day 15, respectively.
Time Frame	Days 8 and 15

Outcome Measure Data

Analysis Population Description

The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.

Arm/Group Title	Gabapentin
Arm/Group Description:	The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time. The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days.
Overall Number of Participants Analyzed	1
Measure Type: Number; Unit of Measure: Ratio
Day 8	1.15
Day 15	1.37

Adverse Events

Time Frame	From Day -7 (informed consent) until 28 days after the end of study treatment
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Gabapentin
Arm/Group Description	The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time. The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days.
All-Cause Mortality
	Gabapentin
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Gabapentin
	Affected / at Risk (%)
Total	0/1 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Gabapentin
	Affected / at Risk (%)
Total	0/1 (0.00%)

Limitations and Caveats

The study was completed with an enrollment of 1 subject because prolongation of the study period or a change in the inclusion criteria (the upper limit of age was deleted) did not lead to further enrollment of subjects.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

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 ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
• ClinicalTrials.gov Identifier: NCT00785772
• Other Study ID Numbers: A9451169
• First Submitted: November 3, 2008
• First Posted: November 5, 2008
• Results First Submitted: March 29, 2011
• Results First Posted: April 27, 2011
• Last Update Posted: February 3, 2021