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Pharmacokinetic Interaction Between Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects

This study has been terminated.
(The trial prematurely terminated on November 1, 2010, due to healthy volunteer participants experiencing non-serious fosamprenavir-related skin rash.)
Sponsor:
Collaborator:
Pfizer
Information provided by:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01140412
First received: June 7, 2010
Last updated: February 3, 2011
Last verified: February 2011
History of Changes

June 7, 2010
February 3, 2011
July 2010
October 2010   (final data collection date for primary outcome measure)
  • Maraviroc plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ on Period 1, Day 5 and Period 2, Day 20 [ Time Frame: 25 days ] [ Designated as safety issue: No ]
  • Amprenavir and ritonavir plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ on Period 2, Day 10 and Period 2, Day 20 [ Time Frame: 25 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01140412 on ClinicalTrials.gov Archive Site
  • Maraviroc plasma pharmacokinetic parameter: Tmax on Period 1, Day 5 and Period 2, Day 20. [ Time Frame: 25 days ] [ Designated as safety issue: No ]
  • Amprenavir and ritonavir plasma pharmacokinetic parameter: Tmax, on Period 2, Day 10 and Period 2, Day 20. [ Time Frame: 25 days ] [ 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 ]
  • Maraviroc plasma pharmacokinetic parameter: Tmax on Period 1, Day 5 and Period 2, Day 20. [ Time Frame: 25 days ] [ Designated as safety issue: No ]
  • Amprenavir and ritonavir plasma pharmacokinetic parameter: Tmax, on Period 2, Day 10 and Period 2, Day 20. [ Time Frame: 25 days ] [ 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 ]
Not Provided
Not Provided
 
Pharmacokinetic Interaction Between Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects
Open-Label, Fixed-Sequence, Crossover Study To Estimate The Pharmacokinetic Interaction Between Multiple Dose Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • 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
  • Drug: Maraviroc
    maraviroc 300 mg QD x 5 days
    Other Name: Selzentry, Celsentri
  • 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
  • Experimental: Cohort 1
    Twice daily regimen
    Interventions:
    • Drug: Maraviroc
    • Drug: Fosamprenavir/ritonavir
    • Drug: Maraviroc + Fosamprenavir/ritonavir
  • Experimental: Cohort 2
    Once daily regimen
    Interventions:
    • Drug: Maraviroc
    • Drug: Fosamprenavir/ritonavir
    • Drug: Maraviroc + Fosamprenavir/ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
14
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
  • Total body weight >45 kg (99 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.
  • Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
  • 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.
Both
21 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01140412
A4001099
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ViiV Healthcare
Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
ViiV Healthcare
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP