Healthy Participants
Conditions
Brief summary
The purpose of this study is to characterize the pharmacokinetics (the way the body absorbs, distributes and eliminates the drug) of BMS 986165 given in the form of various prototypes of solid tablets to healthy participants.
Interventions
DRUGBMS-986165
Specified dose on specified days
DRUGBMS-986165 prototype 1
Specified dose on specified days
DRUGBMS-986165 prototype 2
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * In the opinion of the investigator, a healthy participant is determined by having no clinically significant deviation from normal in medical history, physical examination,electrocardiograms, vital signs, and clinical laboratory determinations. * Body weight \>= 50 kg at screening * Women and men must agree to follow specific methods of contraception, if applicable
Exclusion criteria
* Any major surgery, per investigator's discretion, within 4 weeks of study drug administration * Inability to tolerate oral medication * History of allergy to BMS-986165 or related compounds Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum concentration (Cmax) for BMS-986165 in plasma | Up to 18 days |
| Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T)) for BMS-986165 in plasma | Up to 18 days |
| Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) for BMS-986165 in plasma | Up to 18 days |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with vital sign abnormalities in body temperature | Up to 50 days |
| Number of participants with vital sign abnormalities in respiratory rate | Up to 50 days |
| Number of participants with vital sign abnormalities in heart rate | Up to 50 days |
| Incidence of Adverse Events (AEs) | Up to 23 days |
| Number of participants with clinical laboratory test abnormalities: Hematology tests | Up to 50 days |
| Number of participants with clinical laboratory test abnormalities: Clinical chemistry tests | Up to 50 days |
| Number of participants with clinical laboratory test abnormalities: Urinalysis tests | Up to 50 days |
| Number of participants with vital sign abnormalities in blood pressure | Up to 50 days |
| Incidence of Serious Adverse Events (SAEs) | Up to 55 days |
| Number of clinically significant abnormalities in electrocardiogram (ECG) parameters | Up to 50 days |
Countries
United States
Outcome results
None listed