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Pharmacokinetic Interaction Between Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects

NCT01290211 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2011-06-29

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • ViiV Healthcare

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01290211 on ClinicalTrials.gov