A Pharmacokinetics, Safety and Tolerability Study of Multiple Formulations of BMS-986231 in Healthy Participants

Participants will be randomized 1:1:1:1 and dosed with either of the 4 treatments: A, B, C, or D; followed by review of safety and tolerability data during and after the infusion. The study will proceed with treatments A, and C unless one or more of these treatments shows poor tolerability; in which case the study may proceed with treatment B or D in the follow-up cohorts. Additional participants will be randomized equally to each of the treatments the study will proceed with.

Inclusion criteria

• Participants must be willing to participate in the study and sign the informed consent form (ICF).
• Participants must be willing and able to complete all study-specific procedures and visits.
• Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations in the opinion of the investigator.
• Body mass index of 18.0 to 32.0 kg/m2, inclusive, and body weight ≥ 45 kg and ≤ 110 kg, at screening.
• Heart rate > 45 bpm and < 95 bpm at screening or baseline (within 30 minutes prior to randomization).
• Systolic BP > 110 mmHg and < 140 mmHg at screening or baseline (within 30 minutes prior to randomization).
• Normal renal function at screening as evidenced by an estimated glomerular filtration rate > 80 mL/min/1.732 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.
• Males and females, ages 18 or local age of majority to 40 years, inclusive.

Exclusion criteria

• Any significant acute or chronic medical illness
• Diagnosis of fibromyalgia
• History of syncope, orthostatic instability, or recurrent dizziness
• History or family history of ocular disorders (eg, glaucoma)
• History of bleeding diathesis (unusual susceptibility to bleed [hemorrhage] mostly due to hypocoagulability)
• Personal history or strong family history of sudden cardiac death, myocardial infarction, or other heart disease considered to be clinically significant by the investigator
• Any major surgery within 4 weeks of study drug administration
• History of Gilbert's Syndrome