Estimate the Effect of Telaprevir and Boceprevir on Maraviroc Pharmacokinetics in Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01597895
First received: May 10, 2012
Last updated: September 18, 2012
Last verified: September 2012

May 10, 2012
September 18, 2012
July 2012
August 2012   (final data collection date for primary outcome measure)
Maraviroc plasma pharmacokinetic parameters: AUC12, Cmax, and C12h on Period 1, Day 5 and Periods 2 and 3, Day 10 [ Time Frame: 25 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01597895 on ClinicalTrials.gov Archive Site
  • Maraviroc plasma pharmacokinetic parameters: Tmax on Period 1, Day 5 and Periods 2 and 3, Day 10 [ Time Frame: 25 days ] [ Designated as safety issue: No ]
  • Boceprevir plasma pharmacokinetic parameters: AUC8, Cmax, C8h, and Tmax on Period 2, Day 10 [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Telaprevir plasma pharmacokinetic parameters: AUC8, Cmax, C8h, and Tmax on Period 3, Day 10 [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Estimate the Effect of Telaprevir and Boceprevir on Maraviroc Pharmacokinetics in Healthy Subjects
Open-Label, Randomized, Fixed-Sequence, Crossover Study to Estimate the Effect of Telaprevir and Boceprevir on Maraviroc Pharmacokinetics in Healthy Subjects

The purpose of this study is to determine the effect that telaprevir and boceprevir has on the pharmacokinetics of maraviroc.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
  • Drug: Maraviroc
    Maraviroc 150 mg BID x 5 days with food
  • Drug: Maraviroc + Boceprevir
    Maraviroc 150 mg BID + Boceprevir 800 mg TID x 10 days with food
  • Drug: Maraviroc + Telaprevir
    Maraviroc 150 mg BID + Telaprevir 800 mg TID x 10 days with food
  • Active Comparator: Maraviroc
    Intervention: Drug: Maraviroc
  • Experimental: Maraviroc + Boceprevir
    Intervention: Drug: Maraviroc + Boceprevir
  • Experimental: Maraviroc + Telaprevir
    Intervention: Drug: Maraviroc + Telaprevir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
August 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and/or female subjects.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
  • Total body weight >50 kg (110 lbs).

Exclusion Criteria:

  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
  • Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
  • Positive result for HIV-1, HIV-2, Hepatitis B serology (HbsAg, HbcAb) or anti hepatitis C virus serology (as determined by a multi antigen EIA).
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01597895
A4001108
No
ViiV Healthcare
ViiV Healthcare
Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
ViiV Healthcare
September 2012

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