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:
ViiV Healthcare
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
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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, Crossover Study To Estimate The Pharmacokinetic Interaction Between Multiple Dose Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects |
Resource links provided by NLM:
MedlinePlus related topics:
Drug Reactions
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 ] [ 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 ]
Secondary Outcome Measures:
- 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 ]
| 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 |
| Genders Eligible for Study: | Both |
| 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
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:
No publications provided
| 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 |
| 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:
|
Fosamprenavir Ritonavir Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents |
Enzyme Inhibitors HIV Protease Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protease Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015