Pharmacokinetic Study on Raltegravir and Lamotrigine

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Radboud University
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Anticonvulsants; Lamotrigine; Raltegravir Potassium

Criteria

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