An Investigational Study of Experimental Medication BMS-986231 Given in Participants With Different Levels of Liver Function
Phase 1
Completed
- Conditions
- Liver DysfunctionLiver InsufficiencyHepatic FailureMyocardial FailureHeart DecompensationCardiac FailureCongestive Heart Failure
- Interventions
- Registration Number
- NCT03515980
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
This is an investigational study of experimental Medication BMS-986231 given to participants with weakened or damaged liver function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Moderate hepatic impairment BMS-986231 Based on Hepatic Function Impairment - Child-Pugh B score 7 to 9 points Mild hepatic impairment BMS-986231 Based on Hepatic Function Impairment - Child-Pugh A score 5 to 6 points Normal hepatic function BMS-986231 Based on Hepatic Function Impairment as defined by the investigator Severe hepatic impairment BMS-986231 Based on Hepatic Function Impairment - Child-Pugh C score 10 to 15 points
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 Time of maximum observed plasma concentration (Tmax) Up to 2 days Terminal elimination half-life (t1/2) derived from plasma concentration Up to 2 days 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 Metabolite ratio determined using AUC(INF) for metabolite/AUC(INF) for BMS-986231 [MRAUC(INF)] derived from plasma concentration Up to 2 days
Trial Locations
- Locations (4)
KO-MED Centra Kliniczne Lublin
🇵🇱Lublin, Poland
Semmelweis Egyetem Altalanos Orvostudomanyi Kar
🇭🇺Budapest, Hungary
BioVirtus Centrum Medyczne
🇵🇱Jozefow, Poland
Clinical Research Unit Hungary
🇭🇺Miskolc, Hungary