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

An Open Label Single Dose Study To Investigate Safety And Pharmacokinetics Of Maraviroc Following A Single Oral Dose Of 300 Mg Maraviroc (Two 150 Mg Maraviroc Commercial Tablets) Under Fasting Conditions In Healthy Male Japanese Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00821535

Enrollment

Registered

2009-01-13

Start date

2009-02-28

Completion date

2009-05-31

Last updated

2010-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Immunodeficiency Virus (HIV) Infection

Keywords

pharmacokinetics, Japanese, healthy volunteer, maraviroc

Brief summary

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

Interventions

DRUGmaraviroc (Selzentry, Celsentri)

12 subjects will receive a single dose of 300 mg maraviroc (two 150 mg maraviroc commercial tablets) under fasting conditions.

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

21 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026