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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 27, 2014