Clinical trial NCT01290211: Pharmacokinetic Interaction Between Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects
Official title: Open-Label, Fixed-Sequence Study To Estimate The Pharmacokinetic Interaction Between Multiple Dose Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: maraviroc
fosamprenavir
drug interaction
pharmacokinetics
HIV
AIDS
CCR5
protease inhibitor
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2011-02-04
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maraviroc plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ.
timeFrame: Period 1, Day 5
measure: Maraviroc plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ.
timeFrame: Period 2, Day 20
measure: Amprenavir and ritonavir plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ.
timeFrame: Period 2, Day 10
measure: Amprenavir and ritonavir plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ.
timeFrame: Period 2, Day 20
Secondary outcomes:
measure: Maraviroc plasma pharmacokinetic parameter: Tmax on Period 1, Day 5 and Period 2, Day 20.
timeFrame: Period 1, Day 5
measure: Maraviroc plasma pharmacokinetic parameter: Tmax on Period 1, Day 5 and Period 2, Day 20.
timeFrame: Period 2, Day 20
measure: Amprenavir and ritonavir plasma pharmacokinetic parameter: Tmax, on Period 2, Day 10 and Period 2, Day 20.
timeFrame: Period 2, Day 10
measure: Amprenavir and ritonavir plasma pharmacokinetic parameter: Tmax, on Period 2, Day 10 and Period 2, Day 20.
timeFrame: Period 2, Day 20
measure: Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments.
timeFrame: 25 Days
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: