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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00821535
First received: January 12, 2009
Last updated: November 15, 2010
Last verified: November 2010

January 12, 2009
November 15, 2010
February 2009
May 2009   (final data collection date for primary outcome measure)
  • Plasma and urine maraviroc concentrations for pharmacokinetic analysis [ Time Frame: pre-48 hrs post dose ] [ Designated as safety issue: Yes ]
  • Adverse event monitoring [ Time Frame: Day 0 to Day 3 ] [ Designated as safety issue: No ]
  • Bood pressure, pulse rate [ Time Frame: Day 0, Day 1, and Day 3 ] [ Designated as safety issue: No ]
  • Blood and urine safety laboratory tests [ Time Frame: Day 0 and Day 3 ] [ Designated as safety issue: Yes ]
  • ECG [ Time Frame: Day 0 and Day 3 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00821535 on ClinicalTrials.gov Archive Site
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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

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

Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Human Immunodeficiency Virus (HIV) Infection
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
Active group
maraviroc dosing group
Intervention: Drug: maraviroc (Selzentry, Celsentri)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
May 2009
May 2009   (final data collection date for primary outcome measure)

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.
Male
21 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT00821535
A4001084
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ViiV Healthcare
Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
ViiV Healthcare
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP