Effect of BMS-986165 on the Pharmacokinetics of Rosuvastatin

Bristol-Myers Squibb20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Autoimmune Diseases Inflammatory Diseases

Interventions

BMS-986165DRUG

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.

RosuvastatinDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

PPD Phase I Clinic

Austin, Texas, United States

Outcomes

Primary Outcomes

Cmax (Maximum observed plasma concentration) of Rosuvastatin.

Measured by plasma concentration.

Time frame: 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.

Time frame: 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.

Time frame: Up to Day 13

Secondary Outcomes

Number of Subjects with Deaths.

Measured by investigator assessment.

Time frame: Up till 30 days after discontinuation

Number of Subjects with Serious Adverse Events.

Measured by investigator assessment.

Time frame: Up till 30 days after discontinuation

Number of Subjects with Adverse Events.

Measured by investigator assessment.

Time frame: Up till 30 days after discontinuation

Number of subjects with Adverse Events Leading to Discontinuation.

Measured by investigator assessment.

Time frame: Up till 30 days after discontinuation

Data from ClinicalTrials.gov

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