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Trial record 1 of 1 for:    NCT00821535
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Investigation Of Safety And Pharmacokinetics Following A Single Oral Dose Of 300 Mg Maraviroc In Healthy Male Japanese Volunteers

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ClinicalTrials.gov Identifier: NCT00821535
Recruitment Status : Completed
First Posted : January 13, 2009
Last Update Posted : November 16, 2010
Sponsor:
Collaborator:
Pfizer
Information provided by:
ViiV Healthcare

Tracking Information
First Submitted Date  ICMJE January 12, 2009
First Posted Date  ICMJE January 13, 2009
Last Update Posted Date November 16, 2010
Study Start Date  ICMJE February 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2009)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation Of Safety And Pharmacokinetics Following A Single Oral Dose Of 300 Mg Maraviroc In Healthy Male Japanese Volunteers
Official Title  ICMJE 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
Brief Summary To confirm safety and pharmacokinetics of maraviroc following a single oral dose of 300 mg maraviroc in healthy male Japanese volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Human Immunodeficiency Virus (HIV) Infection
Intervention  ICMJE 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
Study Arms  ICMJE Active group
maraviroc dosing group
Intervention: Drug: maraviroc (Selzentry, Celsentri)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2009)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00821535
Other Study ID Numbers  ICMJE A4001084
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE ViiV Healthcare
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account ViiV Healthcare
Verification Date November 2010

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