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

NCT ID: NCT03515980

Last Updated: 2020-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-25
• Study Completion Date: 2019-08-29

Brief Summary

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

Conditions

Liver Dysfunction; Liver Insufficiency; Hepatic Failure; Myocardial Failure; Cardiac Failure; Congestive Heart Failure; Heart Decompensation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mild hepatic impairment

Based on Hepatic Function Impairment - Child-Pugh A score 5 to 6 points

Group Type: EXPERIMENTAL

BMS-986231

Intervention Type: DRUG

Intravenous (IV) administration

Moderate hepatic impairment

Based on Hepatic Function Impairment - Child-Pugh B score 7 to 9 points

Group Type: EXPERIMENTAL

BMS-986231

Intervention Type: DRUG

Intravenous (IV) administration

Severe hepatic impairment

Based on Hepatic Function Impairment - Child-Pugh C score 10 to 15 points

Group Type: EXPERIMENTAL

BMS-986231

Intervention Type: DRUG

Intravenous (IV) administration

Normal hepatic function

Based on Hepatic Function Impairment as defined by the investigator

Group Type: EXPERIMENTAL

BMS-986231

Intervention Type: DRUG

Intravenous (IV) administration

Interventions

BMS-986231

Intravenous (IV) administration

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Semmelweis Egyetem Altalanos Orvostudomanyi Kar

Budapest, , Hungary

Clinical Research Unit Hungary

Miskolc, , Hungary

BioVirtus Centrum Medyczne

Józefów, , Poland

KO-MED Centra Kliniczne Lublin

Lublin, , Poland

Countries

Hungary; Poland

Related Links

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsstudyconnect.com/s/US/English/USenHome

BMS Clinical Trial Patient Recruiting

https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html

Investigator Inquiry Form

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

2017-004914-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CV013-026

Identifier Type: -

Identifier Source: org_study_id