Investigation Of Safety And Pharmacokinetics Following A Single Oral Dose Of 300 Mg Maraviroc In Healthy Male Japanese Volunteers

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

To confirm safety and pharmacokinetics of maraviroc following a single oral dose of 300 mg maraviroc in healthy male Japanese volunteers.

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

Details

• Lead Sponsor: ViiV Healthcare
• Collaborator: Pfizer
• Treatments: Maraviroc

Criteria

Inclusion Criteria:

• Healthy male Japanese subjects between the ages of 21 and 50 years inclusive.

• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg.

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

• Positive result for HIV, Hepatitis B surface antigen (HbsAg) or HCV antibody.

• Hypersensitivity/allergic reactions to any component of maraviroc, including soy lecithin.