NCT01290211

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Maraviroc	maraviroc 300 mg BID x 5 days
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

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2011-02-04
• Last updated: 2011-06-29

Locations

1 site across 1 country: Belgium