Effect of BMS-986165 on the Pharmacokinetics of Rosuvastatin

Study Overview
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Brief Summary
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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.

Official Title
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Effect of BMS-986165 on the Pharmacokinetics of Rosuvastatin

Conditions
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Autoimmune Diseases, Inflammatory Diseases

Intervention / Treatment
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* Drug: BMS-986165
* Drug: Rosuvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS 986165 and Rosuvastatin<br> | Drug: BMS-986165<br>* Rosuvastatin on Day 1. BMS 986165 on Days 5-8 and Days 10-12. On Day 9, BMS 986165 coadministered with an oral dose of rosuvastatin.<br>Drug: Rosuvastatin<br>* Rosuvastatin on Day 1. BMS 986165 on Days 5-8 and Days 10-12. On Day 9, BMS 986165 coadministered with an oral dose of rosuvastatin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (Maximum observed plasma concentration) of Rosuvastatin. | Measured by plasma concentration. | Up to Day 13 | 
| AUC(0-T) (Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration) of Rosuvastatin. | Measured by plasma concentration. | Up to Day 13 | 
| AUC(INF) (Area under the plasma concentration-time curve from time zero extrapolated to infinite time) of Rosuvastatin. | Measured by plasma concentration. | Up to Day 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects with Deaths. | Measured by investigator assessment. | Up till 30 days after discontinuation | 
| Number of Subjects with Serious Adverse Events. | Measured by investigator assessment. | Up till 30 days after discontinuation | 
| Number of Subjects with Adverse Events. | Measured by investigator assessment. | Up till 30 days after discontinuation | 
| Number of subjects with Adverse Events Leading to Discontinuation. | Measured by investigator assessment. | Up till 30 days after discontinuation |