Healthy Volunteers
Conditions
Brief summary
The purpose of this study is to evaluate the drug levels, safety, and tolerability of BMS-986278 in healthy Chinese participants.
Interventions
DRUGBMS-986278
Specified dose on specified days.
DRUGPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants must be Chinese (both biological parents are ethnically Chinese). * Healthy Chinese male and female (women not of child bearing potential) participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations. * Body mass index of 18.0 to 28.0 kg/m2, inclusive. Body mass index = weight (kg)/(height \[m\])2. * Body weight ≥ 50 kg
Exclusion criteria
* Any significant acute or chronic medical illness that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome * Current or recent (within 3 months of study intervention administration) gastrointestinal (GI) disease that could affect the absorption, distribution, metabolism, and excretion of study drug (eg, bariatric procedure, Gilbert's syndrome) * Any GI surgery (eg, cholecystectomy and any other GI surgery) that, in the opinion of the investigator, could impact the absorption of study treatment (uncomplicated appendectomy and hernia repair are acceptable) * Women who are of childbearing potential * Women who are breastfeeding * Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory determinations beyond what is consistent with the target population. Have abnormal renal function at screening, as evidenced by an estimated glomerular filtration rate \< 90 mL/min/1.732 m\^2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula and the absence of protein in urine Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed concentration (Cmax) | Up to Day 19 |
| Time of maximum observed concentration (Tmax) | Up to Day 19 |
| Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) | Up to Day 19 |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with electrocardiogram (ECG) abnormalities | Up to Day 19 |
| Number of participants with clinical laboratory abnormalities | Up to Day 19 |
| Number of participants with Adverse Events (AEs) | Up to Day 26 |
| Tmax | Up to Day 19 |
| AUC(0-T) | Up to Day 19 |
| Cmax | Up to Day 19 |
| Number of participants with physical examination abnormalities | Up to Day 19 |
| Number of participants with vital sign abnormalities | Up to Day 19 |
Countries
China
Outcome results
None listed