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

Viatris

Status and phase: Terminated; Phase 4

Conditions: Renal Impairment

Treatments: Drug: Gabapentin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00785772

A9451169

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Japanese epilepsy patients with renal impairment

Exclusion criteria

• NA

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 3 patient groups

1: Patients with Cleatinine Clearance (CLcr) 5-14 mL/min

Experimental group

Treatment:

Drug: Gabapentin

Drug: Gabapentin

Drug: Gabapentin

2: Patients with CLcr 15-29 mL/min

Experimental group

Treatment:

Drug: Gabapentin

Drug: Gabapentin

Drug: Gabapentin

3: Patients with CLcr 30-59 mL/min

Experimental group

Treatment:

Drug: Gabapentin

Drug: Gabapentin

Drug: Gabapentin