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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
maraviroc 300 mg BID x 5 days
fosamprenavir/ritonavir 700/100 mg BID x 10 days
maraviroc 300 mg BID + fosamprenavir/ritonavir 700/100 mg BID x 10 days
Pfizer Investigational Site
Brussels, Belgium
Maraviroc plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ.
Time frame: Period 1, Day 5
Maraviroc plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ.
Time frame: Period 2, Day 20
Amprenavir and ritonavir plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ.
Time frame: Period 2, Day 10
Amprenavir and ritonavir plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ.
Time frame: Period 2, Day 20
Maraviroc plasma pharmacokinetic parameter: Tmax on Period 1, Day 5 and Period 2, Day 20.
Time frame: Period 1, Day 5
Maraviroc plasma pharmacokinetic parameter: Tmax on Period 1, Day 5 and Period 2, Day 20.
Time frame: Period 2, Day 20
Amprenavir and ritonavir plasma pharmacokinetic parameter: Tmax, on Period 2, Day 10 and Period 2, Day 20.
Time frame: Period 2, Day 10
Amprenavir and ritonavir plasma pharmacokinetic parameter: Tmax, on Period 2, Day 10 and Period 2, Day 20.
Time frame: Period 2, Day 20
Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments.
Time frame: 25 Days
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maraviroc 300 mg QD x 5 days
fosamprenavir/ritonavir 1400/100 mg QD x 10 days
maraviroc 300 mg QD + fosamprenavir/ritonavir 1400/100 mg QD x 10 days