Pharmacokinetic Study on Raltegravir and Lamotrigine
Information source: Radboud University
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infection
Intervention: lamotrigine alone or combined with raltegravir vise versa (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Radboud University Official(s) and/or principal investigator(s):
David m Burger, PharmD PhD, Principal Investigator, Affiliation: Radboud University
Overall contact:
David M. Burger, PharmD PhD, Phone: +255 748468553, Email: d.burger@akf.umcn.nl
Summary
The purpose of this study is to determine whether interactions between raltegravir and
lamotrigne take place and to study the safety of the combination raltegravir/lamotrigine
before used in HIV patients.
Clinical Details
Official title: The Influence of Raltegravir (MK-0518) on the Pharmacokinetics of Single-Dose Lamotrigine in Healthy Male Subjects (GRANOLA)
Study design: Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacokinetics Study
Primary outcome: Plasma concentrations of lamotrigine, lamotrigine-2N-glucuronide, and raltregravir
Secondary outcome: Determination of pharmacokinetic parameters (AUC, Cmax, Tmax, Cmin and T 1/2) by noncompartmental analysis
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- between 18 and 55 years of age
- subj does not smoke more than 10 cigarettes, 2 cigars of 2 pipes per day
- subj has a quetelet index of 18 to 30kg/m2
- subj is able and willing to sign informed consent
- subj is in a good age-appropriate health condition
- subj 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
Locations and Contacts
David M. Burger, PharmD PhD, Phone: +255 748468553, Email: d.burger@akf.umcn.nl
Radboud University Medical Center, Nijmegen, Gelderland, Netherlands; Recruiting
David Burger, Dr., Principal Investigator
Additional Information
Starting date: February 2008
Ending date: October 2008
Last updated: April 23, 2008
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