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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: BMS-986369

Study type: Interventional

Funder types: Industry

Identifiers

NCT05350800

CA073-001

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

68 participants in 3 patient groups

BMS-986369, Part 1 dose escalation

Experimental group

Treatment:

Drug: BMS-986369

BMS-986369 under fasted conditions, Part 2 Food effect

Experimental group

Treatment:

Drug: BMS-986369

BMS-986369 under fed conditions, Part 2 Food effect

Experimental group

Treatment:

Drug: BMS-986369