An Investigational Study of Experimental Medication BMS-986231 Given in Participants With Different Levels of Liver Function

A Phase 1, Open-Label, Parallel Group, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986231 in Participants With Varying Degrees of Hepatic Impairment

This is an investigational study of experimental Medication BMS-986231 given to participants with weakened or damaged liver function.

Study Overview

• Status: Completed
• Conditions: Congestive Heart Failure; Liver Dysfunction; Heart Decompensation; Cardiac Failure; Liver Insufficiency; Myocardial Failure; Hepatic Failure
• Intervention / Treatment: Drug: BMS-986231

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 1

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem Általános Orvostudományi Kar
  • Miskolc, Hungary, 3529
    • Clinical Research Unit Hungary
• Poland
  • Jozefow, Poland, 05-410
    • BioVirtus Centrum Medyczne
  • Lublin, Poland, 20-954
    • KO-MED Centra Kliniczne LUBLIN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Body weight ≥ 45 kg and ≤ 120 kg and BMI ≥ 18 kg/m2 and ≤ 35 kg/m2
• Heart rate ≥ 50 bpm and < 95 bpm
• Women of childbearing potential must have a negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of study treatment

Exclusion Criteria:

• Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at Screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the volunteer
• History of chronic headaches (defined as occurring 15 days or more a month, over the previous 3 months), headaches related to caffeine withdrawal (ie, coffee, soda, tea, energy drinks, etc.), or moderately severe to severe headaches
• History of migraine or cluster headaches

Other protocol defined inclusion/exclusion criteria could apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mild hepatic impairment; Based on Hepatic Function Impairment - Child-Pugh A score 5 to 6 points	Drug: BMS-986231; Intravenous (IV) administration
Experimental: Moderate hepatic impairment; Based on Hepatic Function Impairment - Child-Pugh B score 7 to 9 points	Drug: BMS-986231; Intravenous (IV) administration
Experimental: Severe hepatic impairment; Based on Hepatic Function Impairment - Child-Pugh C score 10 to 15 points	Drug: BMS-986231; Intravenous (IV) administration
Experimental: Normal hepatic function; Based on Hepatic Function Impairment as defined by the investigator	Drug: BMS-986231; Intravenous (IV) administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(INF)] derived from plasma concentration	Up to 2 days
AUC from time 0 up to time T, where T is the last time point with concentrations above the lower limit of quantitation [AUC(0-T)] derived from plasma concentration	Up to 2 days
Maximum plasma concentration (Cmax)	Up to 2 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events (AE)	Up to 33 days
Incidence of serious adverse events (SAE)	Up to 33 days
Incidence of Laboratory Test Result Abnormalities	Up to 11 days
Clearance (CL) derived from plasma concentration	Up to 2 days
Terminal elimination half-life (t1/2) derived from plasma concentration	Up to 2 days
Time of maximum observed plasma concentration (Tmax)	Up to 2 days
Terminal elimination phase rate constant (λz) derived from plasma concentration	Up to 2 days
Volume of distribution during terminal phase (Vz) derived from plasma concentration	Up to 2 days
Metabolite ratio determined using AUC(INF) for metabolite/AUC(INF) for BMS-986231 [MRAUC(INF)] derived from plasma concentration	Up to 2 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2018
• Primary Completion (Actual): August 29, 2019
• Study Completion (Actual): August 29, 2019

Study Registration Dates

• First Submitted: April 24, 2018
• First Submitted That Met QC Criteria: April 24, 2018
• First Posted (Actual): May 4, 2018

Study Record Updates

• Last Update Posted (Actual): August 27, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Heart Diseases; Cardiovascular Diseases; Liver Diseases; Heart Failure; Liver Failure; Hepatic Insufficiency
• Other Study ID Numbers: CV013-026; 2017-004914-24 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes