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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05350800
• Collaborator: (none)
• Enrollment: 68
• Arms: 3
• Anticipated Duration (Months): 5.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: BMS-986369	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Two-part Study to Evaluate the Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of BMS-986369 and to Explore the Effect of Food on the Bioavailability of BMS-986369 in Healthy Participants
• Anticipated Study Start Date: May 17, 2022
• Anticipated Primary Completion Date: Nov 8, 2022
• Anticipated Study Completion Date: Nov 14, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BMS-986369, Part 1 dose escalation	Drug: BMS-986369; Specified dose on specified days
Experimental: BMS-986369 under fasted conditions, Part 2 Food effect	Drug: BMS-986369; Specified dose on specified days
Experimental: BMS-986369 under fed conditions, Part 2 Food effect	Drug: BMS-986369; Specified dose on specified days

Outcome Measures

Primary Outcome Measures

1. Maximum observed plasma concentration (Cmax) [Day 1]

2. Time of maximum observed plasma concentration (Tmax) [Day 1]

3. Area under the plasma concentration-time curve, from time zero extrapolated to infinite time (AUC(INF)) [Up to 336 hours after dose administration]

Secondary Outcome Measures

1. Number of participants with Adverse Events (AEs) [From the date of having consented until 30 days after completion of study treatment]

2. Number of participants with vital sign abnormalities [Up to Day 15]

3. Number of participants with clinical laboratory abnormalities [Up to Day 15]

4. Number of participants with electrocardiogram (ECG) abnormalities [Up to Day 15]

5. Effect of BMS-986369 on ECG parameters - Part 1 [Up to 72 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts 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/exclusion criteria apply

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT05350800
• Other Study ID Numbers: CA073-001
• First Posted: Apr 28, 2022
• Last Update Posted: Apr 28, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bristol-Myers Squibb: BMS-986369; Healthy Volunteer; CC-99282

Study Results

No Results Posted as of Apr 28, 2022