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Active, Not Recruiting

A Pharmacokinetics, Safety and Tolerability Study of Multiple Formulations of BMS-986231 in Healthy Participants - CV013-038

Updated: 05 June, 2019   |   ClinicalTrials.gov

Print Friendly Summary

Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1


  • Gender(s)

  • 18-40

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
Active Comparator: Treatment A: BMS-986231 Formulation A
Drug: BMS-986231 Formulation A
Experimental: Treatment B: BMS-986231 Formulation B
Drug: BMS-986231 Formulation B
Experimental: Treatment C: BMS-986231 Formulation C
Drug: BMS-986231 Formulation C
Experimental: Treatment D: BMS 986231 Formulation D
Drug: BMS-986231 Formulation D

Key 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

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