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Pharmacokinetic Study on Raltegravir and Lamotrigine — GRANOLA  

HIV Infection Clinical Trial

Official title:
The Influence of Raltegravir (MK-0518) on the Pharmacokinetics of Single-dose Lamotrigine in Healthy Male Subjects (GRANOLA)

Clinical Trial Summary

The purpose of this study is to determine whether interactions between raltegravir and lamotrigine take place and to study the safety of the combination raltegravir/lamotrigine before used in HIV patients.

Clinical Trial Description

Lamotrigine is an anticonvulsive drug that is used both for the treatment of HIV-associated neuropathic pain and the treatment of epilepsy in HIV-infected individuals. Lamotrigine is metabolized via glucuronidation. Raltegravir is a newly developed integrase inhibitor that is also metabolized via glucuronidation. Since both agents are metabolized via glucuronidation, there is a possibility of competition for glucuronidation, leading to drug-drug interactions between raltegravir and lamotrigine. This primary objective of this study is to determine the effect of raltegravir on the pharmacokinetics of single dose lamotrigine (by intrasubject comparison). A secondary objective is to determine the effect of single dose lamotrigine on the pharmacokinetics of raltegravir when compared to historical controls. Another secondary objective is to evaluate the safety of combined use of single dose lamotrigine and raltegravir. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00618241
Study type Interventional
Source Radboud University
Contact
Status Completed
Phase Phase 1
Start date February 2008
Completion date October 2008
View Details
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