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

NCT00821535 | Completed Phase 1

• 1 other identifier: A4001084
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Human Immunodeficiency Virus (HIV) Infection

Keywords

pharmacokinetics, Japanese, healthy volunteer, maraviroc

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Active group

OTHER

maraviroc dosing group

Drug: maraviroc (Selzentry, Celsentri)

Interventions

maraviroc (Selzentry, Celsentri) DRUG

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

Also known as: Selzentry, Celsentri

Active group

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ViiV Healthcare: lead
• Pfizer: collaborator

Study Sites (1)

Pfizer Investigational Site

Singapore, 188770, Singapore

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Maraviroc

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 12, 2009
• First Posted: January 13, 2009
• Study Start: February 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: November 16, 2010

Record last verified: 2010-11

Locations

SG (1)