Cardiac Failure, Congestive Heart Failure, Heart Decompensation, Hepatic Failure, Liver Dysfunction, Liver Insufficiency, Myocardial Failure
Conditions
Brief summary
This is an investigational study of experimental Medication BMS-986231 given to participants with weakened or damaged liver function.
Interventions
DRUGBMS-986231
Intravenous (IV) administration
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion 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/
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Incidence of adverse events (AE) | Up to 33 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 |
| Terminal elimination phase rate constant (λz) derived from plasma concentration | Up to 2 days |
| Incidence of serious adverse events (SAE) | Up to 33 days |
| Incidence of Laboratory Test Result Abnormalities | Up to 11 days |
Countries
Hungary, Poland
Outcome results
None listed