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

• Status: Completed
• Trial end date: 2019-07-29
• Target enrollment: 0
• Participant gender: All

Summary

Main Objective of this study is to compare the single intravenous (IV) infusion pharmacokinetics (PK) of BMS-986231 and its metabolites (BMT-284730, BMT-279554, and CAR-000463) following of up to 2 test formulations of BMS-986231 relative to the reference formulation.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

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