drugset / Trial / NCT01140412

Pharmacokinetic Interaction Between Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects

NCT01140412 ↗

Phase 1 Terminated 14 enrolled ViiV Healthcare Pfizer · collab
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2010-07
Primary completion
2010-10
Completion
2010-10

Outcome

Outcome not reported

Stopped: “The trial prematurely terminated on November 1, 2010, due to healthy volunteer participants experiencing non-serious fosamprenavir-related skin rash.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Fosamprenavir Small molecule 700 mg —
Subject Fosamprenavir Small molecule 1400 mg —
Subject Maraviroc Other / unclassified 300 mg —
Subject Ritonavir Other / unclassified 100 mg —

Indications

No indication recorded.