NCT03891108
A Pharmacokinetics, Safety and Tolerability Study of Multiple Formulations of BMS-986231 in Healthy Participants
Sponsored by Bristol-Myers Squibb
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.
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
PRA Health Sciences
Salt Lake City, Utah, United States
Identity-resolution confidence concerns registry/entity resolution and does not determine clinical eligibility.
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