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NCT00618241 Clinical Trial

Pharmacokinetic Study on Raltegravir and Lamotrigine

HIV Infection Clinical Trial

— GRANOLA  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00618241
Other study ID # UMCN-AKF 07.06
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 2008
Est. completion date October 2008

Study information
Verified date May 2011
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Between 18 and 55 years of age - Subject does not smoke more than 10 cigarettes, 2 cigars or 2 pipes per day - Subject has a Quetelet Index of 18 to 30 kg/m2 - Subject is able and willing to sign informed consent - Subject is in good age-appropriate health condition - Subject has a normal blood pressure and pulse rate Exclusion Criteria: - History of sensitivity/idiosyncrasy to medicinal products or excipients - Positive HIV test - Positive hepatitis B or C test - Therapy with any drug (2 weeks preceding dosing) except for paracetamol - Relevant history or presence of pulmonary disorders, cardiovascular - History of or current abuse of drugs, alcohol or solvents - Inability to understand the nature and extent of the trial and procedures - Participation in a drug trial within 60 days prior to the first dose - Donation of blood within 60 days prior to the first dose - Febrile illness within 3 days before the first dose

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• lamotrigine
100 mg
• Raltegravir
400 mg BD

Locations
Country Name City State
Netherlands Radboud University Medical Center Nijmegen Gelderland

Sponsors (2)
Lead Sponsor Collaborator
Radboud University Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

van Luin M, Colbers A, Verwey-van Wissen CP, van Ewijk-Beneken-Kolmer EW, van der Kolk M, Hoitsma A, da Silva HG, Burger DM. The effect of raltegravir on the glucuronidation of lamotrigine. J Clin Pharmacol. 2009 Oct;49(10):1220-7. doi: 10.1177/0091270009 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma concentrations of lamotrigine, lamotrigine-2N-glucuronide, and raltregravir just before dosing, at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 24 hours and 48 hours after dosing on study days 4-5 and 32-33.
Secondary Determination of pharmacokinetic parameters (AUC, Cmax, Tmax, Cmin and T 1/2) by noncompartmental analysis at each sampling time
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