Pharmacokinetic Interaction Between Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects
Information source: ViiV Healthcare
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Maraviroc (Drug); Fosamprenavir/ritonavir (Drug); Maraviroc + Fosamprenavir/ritonavir (Drug); Maraviroc (Drug); Fosamprenavir/ritonavir (Drug); Maraviroc + Fosamprenavir/ritonavir (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: ViiV Healthcare Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
Official title: Open-Label, Fixed-Sequence Study To Estimate The Pharmacokinetic Interaction Between Multiple Dose Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Maraviroc plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ.Maraviroc plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ. Amprenavir and ritonavir plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ. Amprenavir and ritonavir plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ.
Secondary outcome: Maraviroc plasma pharmacokinetic parameter: Tmax on Period 1, Day 5 and Period 2, Day 20.Maraviroc plasma pharmacokinetic parameter: Tmax on Period 1, Day 5 and Period 2, Day 20. Amprenavir and ritonavir plasma pharmacokinetic parameter: Tmax, on Period 2, Day 10 and Period 2, Day 20. Amprenavir and ritonavir plasma pharmacokinetic parameter: Tmax, on Period 2, Day 10 and Period 2, Day 20. Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
Locations and Contacts
Pfizer Investigational Site, Bruxelles B-1070, Belgium
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: April 2011
Last updated: June 27, 2011
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