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

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

Detailed Description
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Drug interaction study

Official Title
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An Open Label Phase 4 Study To Evaluate An Interaction Between Maraviroc And Raltegravir In Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Maraviroc
* Drug: Maraviroc
* Drug: Raltegravir
* Drug: Raltegravir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maraviroc alone<br> | Drug: Maraviroc<br>* 300 milligrams(mg) every 12 hours Days 6-11<br>* Other names: Selzentry, Celsentri;|
| Experimental: Maraviroc + Raltegravir<br> | Drug: Maraviroc<br>* Days 12-14: Raltegravir 400 milligrams(mg) every 12 hours, maraviroc 300 milligrams(mg) every 12 hours (AM doses only on Day 14)<br>Drug: Raltegravir<br>* Days 12-14: Raltegravir 400 milligrams(mg) every 12 hours, maraviroc 300 milligrams(mg) every 12 hours (AM doses only on Day 14)<br>|
| Experimental: Raltegravir alone<br> | Drug: Raltegravir<br>* 400 milligrams(mg) every 12 hours Days 1-3 Followed by washout Days 4-5<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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). | 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. | Days 3 and 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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maraviroc, raltegravir, drug interaction study, healthy volunteers