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OpenTrials
Completed

NCT Number: NCT00821535

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

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

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Key information

Conditions

Human Immunodeficiency Virus (HIV) Infection Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

21 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Singapore, 188770

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

maraviroc (Selzentry, Celsentri)

Drug

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

Other names: Selzentry, Celsentri

Primary outcomes

  1. Plasma and urine maraviroc concentrations for pharmacokinetic analysis

    Time frame: pre-48 hrs post dose

  2. Adverse event monitoring

    Time frame: Day 0 to Day 3

  3. Bood pressure, pulse rate

    Time frame: Day 0, Day 1, and Day 3

  4. Blood and urine safety laboratory tests

    Time frame: Day 0 and Day 3

  5. ECG

    Time frame: Day 0 and Day 3

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

  • Pfizer

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 13, 2009
Registry last updated
Nov 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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