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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

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

Treatments: Drug: BMS-986231

Study type: Interventional

Funder types: Industry

Identifiers

NCT03515980

CV013-026

2017-004914-24 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 76 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

76 participants in 4 patient groups

Mild hepatic impairment

Experimental group

Description:

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

Treatment:

Drug: BMS-986231

Moderate hepatic impairment

Experimental group

Description:

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

Treatment:

Drug: BMS-986231

Severe hepatic impairment

Experimental group

Description:

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

Treatment:

Drug: BMS-986231

Normal hepatic function

Experimental group

Description:

Based on Hepatic Function Impairment as defined by the investigator

Treatment:

Drug: BMS-986231