A Study To Evaluate An Interaction Between Maraviroc And Raltegravir In Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00666705
First received: April 23, 2008
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

An open label study to evaluate an interaction between maraviroc and raltegravir in healthy subjects.


Condition Intervention Phase
Healthy
Drug: Maraviroc
Drug: Raltegravir
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: An Open Label Phase 4 Study To Evaluate An Interaction Between Maraviroc And Raltegravir In Healthy Subjects

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • Maraviroc Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ) [ Time Frame: Days 11 and 14 ] [ Designated as safety issue: No ]
    Effect of raltegravir on pharmacokinetics of maraviroc (comparison of AUCτ of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir).

  • Maraviroc Pharmacokinetic (PK) Parameter: Maximum Concentration (Cmax) [ Time Frame: Days 11 and 14 ] [ Designated as safety issue: No ]
    Effect of raltegravir on pharmacokinetics of maraviroc (comparison of Cmax of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir). Cmax is the maximum plasma concentration.

  • Raltegravir Pharmacokinetics (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ) [ Time Frame: Days 3 and 14 ] [ Designated as safety issue: No ]
    Effect of maraviroc on pharmacokinetics of raltegravir (comparison of AUCτ of raltegravir co-administered with maraviroc (Test) versus raltegravir administered alone (Reference)). Pharmacokinetics were assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir).

  • Raltegravir Pharmacokinetics (PK) Parameter: Maximum Concentration (Cmax) [ Time Frame: Days 3 and 14 ] [ Designated as safety issue: No ]
    Effect of maraviroc on pharmacokinetics of raltegravir (comparison of Cmax of raltegravir co-administered with maraviroc (Test) versus raltegravir administered alone (Reference)). Pharmacokinetics assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir). Cmax is the maximum plasma concentration.


Other Outcome Measures:
  • Maraviroc Pharmacokinetic (PK) Parameter: 12-Hour Trough Concentration (C12) [ Time Frame: Days 11 and 14 ] [ Designated as safety issue: No ]
    Effect of raltegravir on pharmacokinetics of maraviroc (comparison of C12 of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir). C12 is the 12-hour trough concentration.

  • Raltegravir Pharmacokinetics (PK) Parameter: 12-Hour Trough Concentration (C12) [ Time Frame: Days 3 and 14 ] [ Designated as safety issue: No ]
    Effect of maraviroc on pharmacokinetics of raltegravir (comparison of C12 of raltegravir co-administered with maraviroc (Test) vs. raltegravir administered alone (Reference)). Pharmacokinetics were assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir). C12 is the 12-hour trough concentration.


Enrollment: 18
Study Start Date: February 2008
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Maraviroc alone Drug: Maraviroc
300 milligrams(mg) every 12 hours Days 6-11
Other Name: Selzentry, Celsentri
Experimental: Maraviroc + Raltegravir Drug: Maraviroc
Days 12-14: Raltegravir 400 milligrams(mg) every 12 hours, maraviroc 300 milligrams(mg) every 12 hours (AM doses only on Day 14)
Drug: Raltegravir
Days 12-14: Raltegravir 400 milligrams(mg) every 12 hours, maraviroc 300 milligrams(mg) every 12 hours (AM doses only on Day 14)
Experimental: Raltegravir alone Drug: Raltegravir
400 milligrams(mg) every 12 hours Days 1-3 Followed by washout Days 4-5

Detailed Description:

Drug interaction study

  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 between 18 and 55 years of age.

Exclusion Criteria:

  • Evidence or history of clinically significant disease or clinical findings at screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00666705

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
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: NCT00666705     History of Changes
Other Study ID Numbers: A4001082
Study First Received: April 23, 2008
Results First Received: March 5, 2009
Last Updated: January 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by ViiV Healthcare:
maraviroc
raltegravir
drug interaction study
healthy volunteers

ClinicalTrials.gov processed this record on April 17, 2014