Pharmacokinetic Interaction Between Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: Maraviroc; Drug: Fosamprenavir/ritonavir; Drug: Maraviroc + Fosamprenavir/ritonavir

• Registration Number: NCT01140412
• Lead Sponsor: ViiV Healthcare

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-07
• Study First Submitted QC: 2010-06-07
• Study First Posted: 2010-06-09
• Study Start: 2010-07
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-03
• Last Update Posted: 2011-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
• Total body weight >45 kg (99 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.
• Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort 2	Maraviroc	Once daily regimen
Cohort 1	Maraviroc	Twice daily regimen
Cohort 1	Maraviroc + Fosamprenavir/ritonavir	Twice daily regimen
Cohort 2	Maraviroc + Fosamprenavir/ritonavir	Once daily regimen
Cohort 1	Fosamprenavir/ritonavir	Twice daily regimen
Cohort 2	Fosamprenavir/ritonavir	Once daily regimen

Primary Outcome Measures

Name	Time	Method
Maraviroc plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ on Period 1, Day 5 and Period 2, Day 20	25 days
Amprenavir and ritonavir plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ on Period 2, Day 10 and Period 2, Day 20	25 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore