Facebook Icon Print Created with Sketch. Twitter Icon Created with Sketch. Created with Sketch. LinkedIn Icon Green Check Icon Created with Sketch. YouTube Icon Right Arrow Icon Mobile Menu Icon Chevron Right Icon Phone Icon Health Study Area: AutoImmune Disease Health Study Area: Blood Cancer Health Study Area: Cardiovascular Disease Health Study Area: Fibrosis Health Study Area: Gastrointestinal Cancer Health Study Area: Genitourinary Health Study Area: Head and Neck Cancer Health Study Area: Lung Cancer Health Study Area: Melanoma Health Study Area: Women's Cancer For Caregivers For Clinicians Communities FAQs For Parents For Patients Chevron Icon Bookmark Icon Map Icon Share Icon Direction Arrow Icon Direction Arrow Icon Page Icon Location Icon Search Icon External Link Icon Help Icon Error Icon Glossary Email Icon Gender Both Gender Male Gender Female Created with Sketch. Created with Sketch.

Please Log In/Join Now first, and then use this function!

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

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participants 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

    Phase

  • Gender(s)

  • 18-40

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
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

Have questions? Live support is available 24/7 - Call 855-907-3286 or Email Us

Have questions? Live support is available 24/7 -
Call 855-907-3286 or Email Us