Effect of BMS-986165 on the Pharmacokinetics of Rosuvastatin



Status:Recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 50
Updated:2/24/2017
Start Date:February 2, 2017
End Date:March 2017
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Email:Clinical.Trials@bms.com

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The study is to assess the effect of coadministration of multiple doses of BMS-986165 on the
systemic exposure of rosuvastatin in healthy participants.


Inclusion Criteria:

1. Signed Informed Consent

2. Healthy male and female participants (not of childbearing potential) as determined by
no clinically significant deviation from normal in medical history, physical exam,
ECGs, and clinical laboratory determinations

3. Subjects with body mass index of 18 to 32 kg/m2, inclusive.

4. Women participants must have documented proof that they are not of childbearing
potential.

5. Men who are sexually active with WOCBP must agree to follow instructions for
method(s) of highly effective contraception for the duration of study treatment(s)
plus 5 half-lives of BMS-986165 (4 days) plus 90 days (duration of sperm turnover)
for a total of 94 days of post BMS-986165 treatment. In addition, male participants
must be willing to refrain from sperm donation during this time.

Exclusion Criteria:

1. History of allergy to BMS-986165, rosuvastatin, or related compounds, of myalgia or
rhabdomyolysis while taking rosuvastatin or related compounds or any other drug
allergy

2. Any significant acute or chronic medical illness, active TB requiring treatment or
documented latent TB within the previous 3 years, current or recent gastrointestinal
disease, current or recent history of nausea, vomiting, constipation or irregular
bowel movement

3. History of chronic headaches, syncope, orthostatic instability, or recurrent
dizziness, biliary disorders, drug-induced acne or rash, fibromyalgia, neutropenia or
thrombocytopenia

4. Smokers who currently smoke, recent drug or alcohol abuse, blood transfusion within 4
weeks of study treatment administration, current skin findings that could interfere
with the interpretation of study

Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
1
site
Austin, Texas 78744
Phone: 512-747-4778
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from
Austin, TX
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