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

Phase 4

Terminated

• Conditions: Renal Impairment
• Interventions: Drug: Gabapentin

• Registration Number: NCT00785772
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

The primary objectives of this study are to evaluate the pharmacokinetics (PK) following administration of gabapentin in Japanese epileptic patients with renal impairment to confirm if there are any clinically relevant differences between the plasma gabapentin concentration simulated by population PK model, which was used for the evidence of the dose adjustment for the patients with renal impairment, and observed plasma gabapentin concentration.

Detailed Description

Only one subject was able to be enrolled. Given enrollment challenges to identify additional appropriate subjects, discussion was held with the Japan Pharmaceuticals and Medical Devices Agency (PMDA) and it was agreed with the PMDA to terminate this study. The study was terminated on December 14, 2010. The study was not terminated due to any safety findings.

Study Timeline

• Study First Submitted: 2008-11-03
• Study First Submitted QC: 2008-11-03
• Study First Posted: 2008-11-05
• Study Start: 2010-03
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Results First Submitted: 2011-03-29
• Results First Submitted QC: 2011-03-29
• Results First Posted: 2011-04-27
• Status Verified: 2011-10
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Japanese epilepsy patients with renal impairment

Exclusion Criteria

• NA

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1: Patients with Cleatinine Clearance (CLcr) 5-14 mL/min	Gabapentin	-
2: Patients with CLcr 15-29 mL/min	Gabapentin	-
3: Patients with CLcr 30-59 mL/min	Gabapentin	-

Primary Outcome Measures

Name	Time	Method
Observed Plasma Gabapentin Concentration	Days 8 and 15	Plasma gabapentin concentrations were measured on Day 8 and Day 15
Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration	Days 8 and 15	Ratio of observed plasma gabapentin concentration to individual predicted plasma gabapentin concentration were calculated on Day 8 and Day 15, respectively.
Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model	Days 8 and 15	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Saijyo-shi, Ehime, Japan

Pfizer Investigational Site

🇯🇵Saijyo-shi, Ehime, Japan