BMS-986369 under fasted conditions, Part 2 Food effect for Healthy Subjects

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Healthy SubjectsBMS-986369 - Drug
Eligibility
18 - 55
All Sexes
What conditions do you have?
Select

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

1 of 3

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

1 of 3

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: Drug
BMS-986369 under fed conditions, Part 2 Food effect
Drug
Experimental Group · 1 Intervention: BMS-986369 · Intervention Types: Drug
BMS-986369, Part 1 dose escalation
Drug
Experimental Group · 1 Intervention: BMS-986369 · Intervention Types: Drug

Trial 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.