Pharmacokinetic Interaction Between Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Maraviroc; Drug: Fosamprenavir/ritonavir; Drug: Maraviroc + Fosamprenavir/ritonavir; Drug: Maraviroc; Drug: Fosamprenavir/ritonavir; Drug: Maraviroc + Fosamprenavir/ritonavir

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, B-1070
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: ViiV Healthcare
• Collaborators: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: February 3, 2011
• First Submitted That Met QC Criteria: February 3, 2011
• First Posted (Estimate): February 4, 2011

Study Record Updates

• Last Update Posted (Estimate): June 29, 2011
• Last Update Submitted That Met QC Criteria: June 27, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: HIV; pharmacokinetics; AIDS; drug interaction; protease inhibitor; CCR5; fosamprenavir; maraviroc
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; HIV Fusion Inhibitors; Viral Fusion Protein Inhibitors; CCR5 Receptor Antagonists; Ritonavir; Maraviroc; Fosamprenavir
• Other Study ID Numbers: A4001103