Pharmacokinetic Study on Raltegravir and Lamotrigine (GRANOLA)
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|ClinicalTrials.gov Identifier: NCT00618241|
Recruitment Status : Completed
First Posted : February 19, 2008
Last Update Posted : June 7, 2011
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection||Drug: lamotrigine Drug: Raltegravir||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Influence of Raltegravir (MK-0518) on the Pharmacokinetics of Single-dose Lamotrigine in Healthy Male Subjects (GRANOLA)|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||October 2008|
Group A: day 1-5 Raltegravir 400 mg oral BD (twice daily). Lamotrigine one oral dose 100 mg on day 4. Wash-out 6-31. Followed by one oral dose Lamotrigine 100 mg on day 34.
5 days Raltegravir 400 mg oral BD. Lamotrigine one oral dose 100mg on day 34.
Other Name: Lamictal
400 mg BD
Active Comparator: B
Group B: day 4 Lamotrigine one oral dose on day 4. Wash-out day 6-28 followed by Raltegravir 400 mg oral BD day 29-33. One dose Lamotrigine 100 mg oral on day 32.
One dose Lamotrigine 100 mg oral.
Other Name: Lamictal
400 mg BD
- Plasma concentrations of lamotrigine, lamotrigine-2N-glucuronide, and raltregravir [ Time Frame: 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. ]
- Determination of pharmacokinetic parameters (AUC, Cmax, Tmax, Cmin and T 1/2) by noncompartmental analysis [ Time Frame: at each sampling time ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00618241
|Radboud University Medical Center|
|Nijmegen, Gelderland, Netherlands|
|Principal Investigator:||David M. Burger, PharmD PhD||Radboud University|