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

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 Intervention Model: Crossover Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Ritonavir Fosamprenavir Fosamprenavir sodium Fosamprenavir calcium Maraviroc

U.S. FDA Resources

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:

Maraviroc plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ on Period 1, Day 5 and Period 2, Day 20 [ Time Frame: 25 days ]
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:

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


Enrollment:	14
Study Start Date:	July 2010
Study Completion Date:	October 2010
Primary Completion Date:	October 2010 (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 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

Eligibility


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

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: 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

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
Study First Received:	June 7, 2010
Last Updated:	February 3, 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

ClinicalTrials.gov processed this record on July 19, 2017

To Top