Pharmacokinetic Interaction Between Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects

ViiV Healthcare

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Maraviroc; Drug: Maraviroc + Fosamprenavir/ritonavir; Drug: Fosamprenavir/ritonavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01290211

A4001103

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Twice daily regimen

Treatment:

Drug: Fosamprenavir/ritonavir

Drug: Maraviroc

Drug: Maraviroc + Fosamprenavir/ritonavir

Drug: Maraviroc

Drug: Fosamprenavir/ritonavir

Drug: Maraviroc + Fosamprenavir/ritonavir

Cohort 2

Experimental group

Description:

Once daily regimen

Treatment:

Drug: Fosamprenavir/ritonavir

Drug: Maraviroc

Drug: Maraviroc + Fosamprenavir/ritonavir

Drug: Maraviroc

Drug: Fosamprenavir/ritonavir

Drug: Maraviroc + Fosamprenavir/ritonavir