A Open-label, Drug-Drug Interaction With Maraviroc (DDI)
Completed · Phase 1
Conditions studied: Infection, Human Immunodeficiency Virus
In brief
This is a Phase 1, open-label, single sequence, two-way interaction study in healthy male and female subjects. For the effect of maraviroc on the pharmacokinetics (PK) of BMS-626529 (the active moiety of BMS-663068), there is no formal hypothesis to be statistically tested. The purpose of this assessment is to estimate the effect of maraviroc on the PK of BMS-626529 when coadministered in healthy subjects. For the effect of BMS-663068 on the PK of maraviroc, the hypothesis to be statistically tested is that BMS-663068 will not have a clinically significant effect on the PK of maraviroc when coadministered in healthy subjects.
Key facts
- Study ID
- NCT02480894
- Run by
- ViiV Healthcare
- People needed
- 112
- Starts
- 2015-07-07
- Expected to finish
- 2015-09-21
- Last updated by the study team
- 2017-09-25
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy male and female nonsmoking subjects ages 18 to 50 years, inclusive with a body mass index of 18.0 to 32.0 kg/m2, inclusive
- Women of childbearing potential must agree to follow instructions for methods of contraception for a total of 34 days post-treatment completion
You may not qualify if…
- Any condition possibly affecting drug absorption
- Pre-existing liver dysfunction
- Any significant acute or chronic medical illness
- Orthostatic intolerance
- Other protocol specified exclusion criteria could apply
Where it is running
- GSK Investigational Site — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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