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NCT00785772 Clinical Trial

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

Renal Impairment Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00785772
Other study ID # A9451169
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date March 2010
Est. completion date April 2010

Study information
Verified date October 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 1
Est. completion date April 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender All
Age group 20 Years to 64 Years
Eligibility Inclusion Criteria: - Japanese epilepsy patients with renal impairment Exclusion Criteria: - NA

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Gabapentin
100-200mg once a day
• Gabapentin
200-500mg once a day
• Gabapentin
400-1000mg (200-500 mg twice a day)

Locations
Country Name City State
Japan Pfizer Investigational Site Saijyo-shi Ehime

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Observed Plasma Gabapentin Concentration Plasma gabapentin concentrations were measured on Day 8 and Day 15 Days 8 and 15
Primary 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
Primary 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
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