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

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: Maraviroc; Drug: Raltegravir

• Registration Number: NCT00666705
• Lead Sponsor: ViiV Healthcare

Brief Summary

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

Detailed Description

Drug interaction study

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Study First Submitted: 2008-04-23
• Study First Submitted QC: 2008-04-23
• Study First Posted: 2008-04-25
• Results First Submitted: 2009-03-05
• Results First Submitted QC: 2009-04-10
• Results First Posted: 2009-06-04
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-16
• Last Update Posted: 2013-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Maraviroc + Raltegravir	Maraviroc	-
Maraviroc + Raltegravir	Raltegravir	-
Maraviroc alone	Maraviroc	-
Raltegravir alone	Raltegravir	-

Primary Outcome Measures

Name	Time	Method
Maraviroc Pharmacokinetic (PK) Parameter: Maximum Concentration (Cmax)	Days 11 and 14	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.
Maraviroc Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)	Days 11 and 14	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).
Raltegravir Pharmacokinetics (PK) Parameter: Maximum Concentration (Cmax)	Days 3 and 14	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.
Raltegravir Pharmacokinetics (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)	Days 3 and 14	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).

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States