Pharmacokinetic Interaction Between Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects

Study Overview
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Brief Summary
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This is will be an open-label, fixed-sequence, multiple dose crossover study in 2 cohorts of 14 healthy male and/or female subjects, to estimate the effect of maraviroc on the pharmacokinetics of amprenavir and ritonavir and fosamprenavir/ritonavir on the pharmacokinetics of maraviroc.

Official Title
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Open-Label, Fixed-Sequence Study To Estimate The Pharmacokinetic Interaction Between Multiple Dose Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Maraviroc
* Drug: Fosamprenavir/ritonavir
* Drug: Maraviroc + Fosamprenavir/ritonavir
* Drug: Maraviroc
* Drug: Fosamprenavir/ritonavir
* Drug: Maraviroc + Fosamprenavir/ritonavir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2. Total body weight >50 kg (110 lbs). Exclusion Criteria: History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening. Positive result for HIV, Hepatitis B or Hepatitis C virus. Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication. Known hypersensitivity or history of allergy to sulfonamides.

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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Twice daily regimen | Drug: Maraviroc<br>* maraviroc 300 mg BID x 5 days<br>* Other names: Selzentry, Celsentri;Drug: Fosamprenavir/ritonavir<br>* fosamprenavir/ritonavir 700/100 mg BID x 10 days<br>Drug: Maraviroc + Fosamprenavir/ritonavir<br>* maraviroc 300 mg BID + fosamprenavir/ritonavir 700/100 mg BID x 10 days<br>|
| Experimental: Cohort 2<br>Once daily regimen | Drug: Maraviroc<br>* maraviroc 300 mg QD x 5 days<br>Drug: Fosamprenavir/ritonavir<br>* fosamprenavir/ritonavir 1400/100 mg QD x 10 days<br>Drug: Maraviroc + Fosamprenavir/ritonavir<br>* maraviroc 300 mg QD + fosamprenavir/ritonavir 1400/100 mg QD x 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maraviroc plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ. |  | Period 1, Day 5 | 
| Maraviroc plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ. |  | Period 2, Day 20 | 
| Amprenavir and ritonavir plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ. |  | Period 2, Day 10 | 
| Amprenavir and ritonavir plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ. |  | Period 2, Day 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maraviroc plasma pharmacokinetic parameter: Tmax on Period 1, Day 5 and Period 2, Day 20. |  | Period 1, Day 5 | 
| Maraviroc plasma pharmacokinetic parameter: Tmax on Period 1, Day 5 and Period 2, Day 20. |  | Period 2, Day 20 | 
| Amprenavir and ritonavir plasma pharmacokinetic parameter: Tmax, on Period 2, Day 10 and Period 2, Day 20. |  | Period 2, Day 10 | 
| Amprenavir and ritonavir plasma pharmacokinetic parameter: Tmax, on Period 2, Day 10 and Period 2, Day 20. |  | Period 2, Day 20 | 
| Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments. |  | 25 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, maraviroc, fosamprenavir, drug interaction, pharmacokinetics, AIDS, CCR5, protease inhibitor