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Pharmacokinetic Study on Raltegravir and Lamotrigine (GRANOLA)

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00618241
First received: February 5, 2008
Last updated: June 6, 2011
Last verified: May 2011

February 5, 2008
June 6, 2011
February 2008
October 2008   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00618241 on ClinicalTrials.gov Archive Site
Determination of pharmacokinetic parameters (AUC, Cmax, Tmax, Cmin and T 1/2) by noncompartmental analysis [ Time Frame: at each sampling time ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetic Study on Raltegravir and Lamotrigine
The Influence of Raltegravir (MK-0518) on the Pharmacokinetics of Single-dose Lamotrigine in Healthy Male Subjects (GRANOLA)

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
  • Drug: lamotrigine
    100 mg
    Other Name: Lamictal
  • Drug: Raltegravir
    400 mg BD
  • Experimental: A

    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.

    Interventions:
    • Drug: lamotrigine
    • Drug: Raltegravir
  • 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.

    Interventions:
    • Drug: lamotrigine
    • Drug: Raltegravir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00618241
UMCN-AKF 07.06
No
Dr. D.M. Burger, hospital pharmacist, Radboud University Nijmegen Medical Centre
Radboud University
Merck Sharp & Dohme Corp.
Principal Investigator: David M. Burger, PharmD PhD Radboud University
Radboud University
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP