Study 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.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 5 Secondary · Reporting Duration: Up to 336 hours after dose administration
Day 1
Maximum observed plasma concentration (Cmax)
Time of maximum observed plasma concentration (Tmax)
Day 30
Number of participants with Adverse Events (AEs)
Hour 336
Area under the plasma concentration-time curve, from time zero extrapolated to infinite time (AUC(INF))
Up to 72 hours
Effect of BMS-986369 on ECG parameters - Part 1
Up to Day 15
Number of participants with clinical laboratory abnormalities
Number of participants with electrocardiogram (ECG) abnormalities
Number of participants with vital sign abnormalities
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
BMS-986369 under fasted conditions, Part 2 Food effect
1 of 3
BMS-986369 under fed conditions, Part 2 Food effect
1 of 3
BMS-986369, Part 1 dose escalation
1 of 3
Experimental Treatment
68 Total Participants · 3 Treatment Groups
Primary Treatment: BMS-986369 under fasted conditions, Part 2 Food effect · No Placebo Group · Phase 1
BMS-986369 under fasted conditions, Part 2 Food effect
Drug
Experimental Group · 1 Intervention: BMS-986369 · Intervention Types: DrugBMS-986369 under fed conditions, Part 2 Food effect
Drug
Experimental Group · 1 Intervention: BMS-986369 · Intervention Types: DrugBMS-986369, Part 1 dose escalation
Drug
Experimental Group · 1 Intervention: BMS-986369 · Intervention Types: DrugTrial Logistics
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 336 hours after dose administration
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,496 Previous Clinical Trials
3,930,259 Total Patients Enrolled
Eligibility Criteria
Age 18 - 55 · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a body mass index (BMI) of 18.0 to 33.0 kg/m2, inclusive.
You 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.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Conditions
Cancer Related
Treatments