Autoimmune Diseases, Inflammatory Diseases
Conditions
Brief summary
The study is to assess the effect of coadministration of multiple doses of BMS-986165 on the systemic exposure of rosuvastatin in healthy participants.
Interventions
DRUGBMS-986165
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.
DRUGRosuvastatin
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.
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax (Maximum observed plasma concentration) of Rosuvastatin. | Up to Day 13 | Measured by plasma concentration. |
| AUC(0-T) (Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration) of Rosuvastatin. | Up to Day 13 | Measured by plasma concentration. |
| AUC(INF) (Area under the plasma concentration-time curve from time zero extrapolated to infinite time) of Rosuvastatin. | Up to Day 13 | Measured by plasma concentration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects with Deaths. | Up till 30 days after discontinuation | Measured by investigator assessment. |
| Number of subjects with Adverse Events Leading to Discontinuation. | Up till 30 days after discontinuation | Measured by investigator assessment. |
| Number of Subjects with Serious Adverse Events. | Up till 30 days after discontinuation | Measured by investigator assessment. |
| Number of Subjects with Adverse Events. | Up till 30 days after discontinuation | Measured by investigator assessment. |
Countries
United States
Outcome results
None listed