Healthy Volunteer
Conditions
Keywords
BMS-986369, Healthy Volunteer, CC-99282
Brief summary
The purpose of this study is to evaluate the safety, tolerability, drug levels of BMS-986369 following administration of single ascending oral doses (SAD) in healthy adult participants. The study will also explore the effect of high-fat meal on the single-dose drug level of BMS-986369 in healthy adult participants.
Interventions
DRUGBMS-986369
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index (BMI) 18.0 to 33.0 kg/m2, inclusive. BMI = weight (kg)/(height \[m\])2 for participants * Must have a normal or clinically-acceptable 12-lead ECG at screening * Absolute neutrophil counts must be greater than 2,500/μL at screening and Day -1
Exclusion criteria
* Any significant acute or chronic medical illness that presents a potential risk to the participant in the opinion of the investigator and/or may compromise the objectives of the study * History of clinically significant endocrine, gastrointestinal (GI), cardiovascular (CV), peripheral vascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary (GU) abnormalities/diseases * History of major surgery within 8 weeks before the first dose administration Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) | Day 1 |
| Time of maximum observed plasma concentration (Tmax) | Day 1 |
| Area under the plasma concentration-time curve, from time zero extrapolated to infinite time (AUC(INF)) | Up to 336 hours after dose administration |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with electrocardiogram (ECG) abnormalities | Up to Day 15 |
| Number of participants with Adverse Events (AEs) | From the date of having consented until 30 days after completion of study treatment |
| Effect of BMS-986369 on ECG parameters - Part 1 | Up to 72 hours |
| Number of participants with vital sign abnormalities | Up to Day 15 |
| Number of participants with clinical laboratory abnormalities | Up to Day 15 |
Countries
United States
Outcome results
None listed