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

Phase 4CompletedNCT00666705

ViiV Healthcare18 enrolled

Overview

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

Drug interaction study

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

MaravirocDRUG

300 milligrams(mg) every 12 hours Days 6-11

MaravirocDRUG

Days 12-14: Raltegravir 400 milligrams(mg) every 12 hours, maraviroc 300 milligrams(mg) every 12 hours (AM doses only on Day 14)

RaltegravirDRUG

Days 12-14: Raltegravir 400 milligrams(mg) every 12 hours, maraviroc 300 milligrams(mg) every 12 hours (AM doses only on Day 14)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Maraviroc Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)

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).

Time frame: Days 11 and 14

Maraviroc Pharmacokinetic (PK) Parameter: Maximum Concentration (Cmax)

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.

Time frame: Days 11 and 14

Raltegravir Pharmacokinetics (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)

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).

Time frame: Days 3 and 14

Raltegravir Pharmacokinetics (PK) Parameter: Maximum Concentration (Cmax)

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.

Time frame: Days 3 and 14

Data from ClinicalTrials.gov

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