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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Renal Impairment

Intervention / Treatment
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* Drug: Gabapentin
* Drug: Gabapentin
* Drug: Gabapentin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Japanese epilepsy patients with renal impairment Exclusion Criteria: NA

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1: Patients with Cleatinine Clearance (CLcr) 5-14 mL/min<br> | Drug: Gabapentin<br>* 100-200mg once a day<br>|
| Experimental: 2: Patients with CLcr 15-29 mL/min<br> | Drug: Gabapentin<br>* 200-500mg once a day<br>|
| Experimental: 3: Patients with CLcr 30-59 mL/min<br> | Drug: Gabapentin<br>* 400-1000mg (200-500 mg twice a day)<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gabapentin Pharmacokinetics