A Open-label, Drug-Drug Interaction With Maraviroc



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 50
Updated:4/21/2016
Start Date:July 2015
End Date:September 2015

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 1, Open-label, Drug-drug Interaction Study Between BMS-663068 and Maraviroc in Healthy Subjects

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 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 pharmacokinetics (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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
1
site
ICON Early Phase Services, LLC (formerly named Healthcare Discveries, LLC)
San Antonio, Texas 78209
?
mi
from
San Antonio, TX
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