Healthy Participants
Conditions
Brief summary
Phase 1 study that assesses the effect of BMS-963272 on exposure of rosuvastatin in healthy participants
Interventions
DRUGrosuvastatin
Specified dose on specified days
DRUGBMS-963272
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations * Women must not be of childbearing potential (WNOCBP) * Women and men must agree to follow instructions for methods of contraception
Exclusion criteria
* Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study. * Any major surgery within 4 weeks of study drug administration * Any blood transfusion or donation of blood to a blood bank or in a clinical study within 4 weeks of study drug administration * Previous treatment with BMS-963272 * Participants who smoke, as well as, those who have stopped smoking less than 6 months prior to day 1 Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum concentration (Cmax) | up to Day 10 |
| Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration AUC(0-T) | up to Day 10 |
| Area under the plasma concentration-time curve extrapolated to infinity AUC (INF) | up to Day 10 |
Secondary
| Measure | Time frame |
|---|---|
| Number of significant changes in lab assessments of urine | Approximately 50 days |
| Blood pressure | Approximately 50 days |
| Body temperature | Approximately 50 days |
| Incidence of Adverse Events (AEs) | Approximately 50 days |
| Number of Participants with abnormal physical examination findings | Approximately 50 days |
| Heart rate | Approximately 50 days |
| Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities | Approximately 50 days |
| Respiratory rate | Approximately 50 days |
| Number of significant changes in lab assessments of blood serum | Approximately 50 days |
| Number of significant changes in lab assessments of blood | Approximately 50 days |
Countries
United States
Outcome results
None listed