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

ViiV Healthcare

Status and phase: Completed; Phase 1

Conditions: Human Immunodeficiency Virus (HIV) Infection

Treatments: Drug: maraviroc (Selzentry, Celsentri)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00821535

A4001084

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: Male

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

12 participants in 1 patient group

Active group

Other group

Description:

maraviroc dosing group

Treatment:

Drug: maraviroc (Selzentry, Celsentri)