A Study to Evaluate the Drug Exposure of Single Ascending Doses of BMS-986369 and the Effect of Food on the BMS-986369 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: BMS-986369

• Registration Number: NCT05350800
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-04-25
• Study First Posted: 2022-04-28
• Study Start: 2022-09-12
• Primary Completion: 2023-05-04
• Study Completion: 2023-05-04
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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/exclusion criteria apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BMS-986369 under fasted conditions, Part 2 Food effect	BMS-986369	-
BMS-986369 under fed conditions, Part 2 Food effect	BMS-986369	-
BMS-986369, Part 1 dose escalation	BMS-986369	-

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax)	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
Time of maximum observed plasma concentration (Tmax)	Day 1

Secondary Outcome Measures

Name	Time	Method
Number of participants with Adverse Events (AEs)	From the date of having consented until 30 days after completion of study treatment
Number of participants with electrocardiogram (ECG) abnormalities	Up to Day 15
Number of participants with clinical laboratory abnormalities	Up to Day 15
Number of participants with vital sign abnormalities	Up to Day 15
Effect of BMS-986369 on ECG parameters - Part 1	Up to 72 hours

Trial Locations

Locations (1)

Local Institution - 0001; 🇺🇸 Miami, Florida, United States