Effect of BMS-986165 on the Pharmacokinetics of Rosuvastatin

Completed · Phase 1

Conditions studied: Autoimmune Diseases, Inflammatory Diseases

In brief

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

Key facts

Study ID

NCT03044873

Run by

Bristol-Myers Squibb

People needed

20

Starts

2017-02-02

Expected to finish

2017-03-27

Last updated by the study team

2017-04-17

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Signed Informed Consent
• 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
• Subjects with body mass index of 18 to 32 kg/m2, inclusive.
• Women participants must have documented proof that they are not of childbearing potential.
• 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.

You may not qualify if…

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

Where it is running

• PPD Phase I Clinic — Austin, Texas, United States

Full record on ClinicalTrials.gov

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