Back to trials
completed
Phase 1

NCT03891108

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

Sponsored by Bristol-Myers Squibb

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.

Eligibility 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

Locations (1)

PRA Health Sciences

Salt Lake City, Utah, United States

Why you can trust this information
Registry sourcesclinicaltrials_gov
Source last updated10/1/2019
Clintriva indexed9/27/2026, 9:21:09 PM
Registry records1
Relationships needing review0

Identity-resolution confidence concerns registry/entity resolution and does not determine clinical eligibility.

Interested in this trial?

Express your interest and we'll connect you with the trial team.

Your selected profile and contact information may be shared with an authorised trial site, sponsor, or Clintriva coordination team for trial contact and pre-screening. Expressing interest does not mean you are eligible or enrolled.

Quick Facts
Start DateFeb 28, 2019
CompletionJul 29, 2019
Enrollment0/60
CountryUnited States

Conditions

Heart Failure
View on registry
Clintriva
GDPR Controls Mapped HIPAA Safeguards Mapped NHS DSP Controls Mapped SOC 2 Controls Mapped

© 2026 Clintriva. All rights reserved.