Pharmacokinetic Interaction Between Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01290211
First received: February 3, 2011
Last updated: June 27, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Maraviroc
Drug: Fosamprenavir/ritonavir
Drug: Maraviroc + Fosamprenavir/ritonavir
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label, Fixed-Sequence Study To Estimate The Pharmacokinetic Interaction Between Multiple Dose Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • Maraviroc plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ. [ Time Frame: Period 1, Day 5 ] [ Designated as safety issue: No ]
  • Maraviroc plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ. [ Time Frame: Period 2, Day 20 ] [ Designated as safety issue: No ]
  • Amprenavir and ritonavir plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ. [ Time Frame: Period 2, Day 10 ] [ Designated as safety issue: No ]
  • Amprenavir and ritonavir plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ. [ Time Frame: Period 2, Day 20 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maraviroc plasma pharmacokinetic parameter: Tmax on Period 1, Day 5 and Period 2, Day 20. [ Time Frame: Period 1, Day 5 ] [ Designated as safety issue: No ]
  • Maraviroc plasma pharmacokinetic parameter: Tmax on Period 1, Day 5 and Period 2, Day 20. [ Time Frame: Period 2, Day 20 ] [ Designated as safety issue: No ]
  • Amprenavir and ritonavir plasma pharmacokinetic parameter: Tmax, on Period 2, Day 10 and Period 2, Day 20. [ Time Frame: Period 2, Day 10 ] [ Designated as safety issue: No ]
  • Amprenavir and ritonavir plasma pharmacokinetic parameter: Tmax, on Period 2, Day 10 and Period 2, Day 20. [ Time Frame: Period 2, Day 20 ] [ Designated as safety issue: No ]
  • Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments. [ Time Frame: 25 Days ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: April 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Twice daily regimen
Drug: Maraviroc
maraviroc 300 mg BID x 5 days
Other Name: Selzentry, Celsentri
Drug: Fosamprenavir/ritonavir
fosamprenavir/ritonavir 700/100 mg BID x 10 days
Drug: Maraviroc + Fosamprenavir/ritonavir
maraviroc 300 mg BID + fosamprenavir/ritonavir 700/100 mg BID x 10 days
Experimental: Cohort 2
Once daily regimen
Drug: Maraviroc
maraviroc 300 mg QD x 5 days
Drug: Fosamprenavir/ritonavir
fosamprenavir/ritonavir 1400/100 mg QD x 10 days
Drug: Maraviroc + Fosamprenavir/ritonavir
maraviroc 300 mg QD + fosamprenavir/ritonavir 1400/100 mg QD x 10 days

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01290211

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, B-1070
Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01290211     History of Changes
Other Study ID Numbers: A4001103
Study First Received: February 3, 2011
Last Updated: June 27, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by ViiV Healthcare:
maraviroc
fosamprenavir
drug interaction
pharmacokinetics
HIV
AIDS
CCR5
protease inhibitor

Additional relevant MeSH terms:
Ritonavir
Fosamprenavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014