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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

Page last updated: August 23, 2015

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