Status:
COMPLETED
Investigation Of Safety And Pharmacokinetics Following A Single Oral Dose Of 300 Mg Maraviroc In Healthy Male Japanese Volunteers
Lead Sponsor:
ViiV Healthcare
Collaborating Sponsors:
Pfizer
Conditions:
Human Immunodeficiency Virus (HIV) Infection
Eligibility:
MALE
21-50 years
Phase:
PHASE1
Brief Summary
To confirm safety and pharmacokinetics of maraviroc following a single oral dose of 300 mg maraviroc in healthy male Japanese volunteers.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00821535
Start Date
February 1 2009
End Date
May 1 2009
Last Update
November 16 2010
Active Locations (1)
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1
Pfizer Investigational Site
Singapore, Singapore, 188770