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
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 April 21, 2014