Effect of BMS-986165 on the Pharmacokinetics of Rosuvastatin

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Inflammatory Diseases; Autoimmune Diseases

Treatments: Drug: Rosuvastatin; Drug: BMS-986165

Study type: Interventional

Funder types: Industry

Identifiers

NCT03044873

IM011-015

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

BMS 986165 and Rosuvastatin

Experimental group

Treatment:

Drug: Rosuvastatin

Drug: BMS-986165