Investigation Of Safety And Pharmacokinetics Following A Single Oral Dose Of 300 Mg Maraviroc In Healthy Male Japanese Volunteers
Phase 1
Completed
- Conditions
- Human Immunodeficiency Virus (HIV) Infection
- Interventions
- Registration Number
- NCT00821535
- Lead Sponsor
- ViiV Healthcare
- Brief Summary
To confirm safety and pharmacokinetics of maraviroc following a single oral dose of 300 mg maraviroc in healthy male Japanese volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Active group maraviroc (Selzentry, Celsentri) maraviroc dosing group
- Primary Outcome Measures
Name Time Method Plasma and urine maraviroc concentrations for pharmacokinetic analysis pre-48 hrs post dose Adverse event monitoring Day 0 to Day 3 Bood pressure, pulse rate Day 0, Day 1, and Day 3 Blood and urine safety laboratory tests Day 0 and Day 3 ECG Day 0 and Day 3
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇸🇬Singapore, Singapore