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Pharmacokinetic Interaction Between Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01140412
Recruitment Status : Terminated (The trial prematurely terminated on November 1, 2010, due to healthy volunteer participants experiencing non-serious fosamprenavir-related skin rash.)
First Posted : June 9, 2010
Last Update Posted : February 4, 2011
Sponsor:
Collaborator:
Pfizer
Information provided by:
ViiV Healthcare

Study Description
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Brief 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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Fixed-Sequence, Crossover Study To Estimate The Pharmacokinetic Interaction Between Multiple Dose Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects
Study Start Date : July 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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
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


Outcome Measures
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Primary Outcome Measures :
  1. Maraviroc plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ on Period 1, Day 5 and Period 2, Day 20 [ Time Frame: 25 days ]
  2. Amprenavir and ritonavir plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ on Period 2, Day 10 and Period 2, Day 20 [ Time Frame: 25 days ]

Secondary Outcome Measures :
  1. Maraviroc plasma pharmacokinetic parameter: Tmax on Period 1, Day 5 and Period 2, Day 20. [ Time Frame: 25 days ]
  2. Amprenavir and ritonavir plasma pharmacokinetic parameter: Tmax, on Period 2, Day 10 and Period 2, Day 20. [ Time Frame: 25 days ]
  3. Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments. [ Time Frame: 25 days ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01140412


Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01140412     History of Changes
Other Study ID Numbers: A4001099
First Posted: June 9, 2010    Key Record Dates
Last Update Posted: February 4, 2011
Last Verified: February 2011

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

Additional relevant MeSH terms:
Ritonavir
Fosamprenavir
Maraviroc
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
CCR5 Receptor Antagonists