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Trial record 11 of 27 for:    " December 17, 2008":" January 16, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study has been completed.
Information provided by:
ViiV Healthcare Identifier:
First received: January 12, 2009
Last updated: November 15, 2010
Last verified: November 2010
To confirm safety and pharmacokinetics of maraviroc following a single oral dose of 300 mg maraviroc in healthy male Japanese volunteers.

Condition Intervention Phase
Human Immunodeficiency Virus (HIV) Infection Drug: maraviroc (Selzentry, Celsentri) Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: 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

Resource links provided by NLM:

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • Plasma and urine maraviroc concentrations for pharmacokinetic analysis [ Time Frame: pre-48 hrs post dose ]
  • Adverse event monitoring [ Time Frame: Day 0 to Day 3 ]
  • Bood pressure, pulse rate [ Time Frame: Day 0, Day 1, and Day 3 ]
  • Blood and urine safety laboratory tests [ Time Frame: Day 0 and Day 3 ]
  • ECG [ Time Frame: Day 0 and Day 3 ]

Enrollment: 12
Study Start Date: February 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active group
maraviroc dosing group
Drug: maraviroc (Selzentry, Celsentri)
12 subjects will receive a single dose of 300 mg maraviroc (two 150 mg maraviroc commercial tablets) under fasting conditions.
Other Name: Selzentry, Celsentri


Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts 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.
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Please refer to this study by its identifier: NCT00821535

Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
ViiV Healthcare
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00821535     History of Changes
Other Study ID Numbers: A4001084
Study First Received: January 12, 2009
Last Updated: November 15, 2010

Keywords provided by ViiV Healthcare:
pharmacokinetics, Japanese, healthy volunteer, maraviroc

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents processed this record on September 19, 2017