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Trial record 46 of 215 for:    Lamotrigine

Pharmacokinetic Study on Raltegravir and Lamotrigine (GRANOLA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00618241
Recruitment Status : Completed
First Posted : February 19, 2008
Last Update Posted : June 7, 2011
Merck Sharp & Dohme Corp.
Information provided by:
Radboud University

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infection Drug: lamotrigine Drug: Raltegravir Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.

Drug: lamotrigine
100 mg
Other Name: Lamictal

Drug: Raltegravir
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.

Drug: lamotrigine
100 mg
Other Name: Lamictal

Drug: Raltegravir
400 mg BD

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. Determination of pharmacokinetic parameters (AUC, Cmax, Tmax, Cmin and T 1/2) by noncompartmental analysis [ Time Frame: at each sampling time ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00618241

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Radboud University Medical Center
Nijmegen, Gelderland, Netherlands
Sponsors and Collaborators
Radboud University
Merck Sharp & Dohme Corp.
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Principal Investigator: David M. Burger, PharmD PhD Radboud University

Additional Information:
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Responsible Party: Dr. D.M. Burger, hospital pharmacist, Radboud University Nijmegen Medical Centre Identifier: NCT00618241     History of Changes
Other Study ID Numbers: UMCN-AKF 07.06
First Posted: February 19, 2008    Key Record Dates
Last Update Posted: June 7, 2011
Last Verified: May 2011
Keywords provided by Radboud University:
neuropathic pain
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Raltegravir Potassium
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Sodium Channel Blockers