Trial record 14 of 16 for:    " April 18, 2012":" May 18, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Maraviroc
Drug: Maraviroc + Boceprevir
Drug: Maraviroc + Telaprevir
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Open-Label, Randomized, Fixed-Sequence, Crossover Study to Estimate the Effect of Telaprevir and Boceprevir on Maraviroc Pharmacokinetics in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 14
Study Start Date: July 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Maraviroc Drug: Maraviroc
Maraviroc 150 mg BID x 5 days with food
Experimental: Maraviroc + Boceprevir Drug: Maraviroc + Boceprevir
Maraviroc 150 mg BID + Boceprevir 800 mg TID x 10 days with food
Experimental: Maraviroc + Telaprevir Drug: Maraviroc + Telaprevir
Maraviroc 150 mg BID + Telaprevir 800 mg TID x 10 days with food

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01597895

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, B-1070
Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01597895     History of Changes
Other Study ID Numbers: A4001108
Study First Received: May 10, 2012
Last Updated: September 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by ViiV Healthcare:
maraviroc
boceprevir
telaprevir
drug interaction
pharmacokinetics
HIV

ClinicalTrials.gov processed this record on April 17, 2014