Cardiac Failure, Myocardial Failure
Conditions
Brief summary
The purpose of this study is to investigate the experimental medication BMS-986224 in participants with varying levels of renal function.
Interventions
DRUGBMS-986224
Specified dose on specified days
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 80 Years
Healthy volunteers
Yes
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * BMI ≥18 and ≤ 35kg/m2 * Systolic blood pressure \>100 mmHg
Exclusion criteria
* Women of childbearing potential or women who are currently pregnant * 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 * Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative amount of unchanged drug excreted into the urine at a given time (Aet) of BMS-986224 | 7 days | Part 1 only |
| Fraction of dose excreted in urine (Fe%) of BMS-986224 | 7 days | Part 1 only |
| Renal clearance of BMS-986224 derived from urine concentration | 7 days | Part 1 only |
| Maximum observed plasma concentration (Cmax) of BMS-986224 | Up to 11 days | — |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986224 | Up to 11 days | — |
| Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of BMS-986224 | Up to 11 days | — |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986224 | Up to 11 days | — |
| Time of maximum observed plasma concentration (Tmax) of BMS-986224 | Up to 11 days | — |
| Terminal elimination half-life (T-HALF) of BMS-986224 derived from plasma concentration | Up to 11 days | — |
| Fraction of unbound drug in plasma (fu) of BMS-986224 | Up to 11 days | — |
| Apparent oral clearance (CL/F) of BMS-986224 derived from plasma concentration | Up to 11 days | — |
| Apparent volume of distribution (Vz/F) of BMS-986224 derived from plasma concentration | Up to 11 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation | Up to 41 days |
| Maximum observed plasma concentration (Cmax) of metabolite | Up to 11 days |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of metabolite | Up to 11 days |
| Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of metabolite | Up to 11 days |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of metabolite | Up to 11 days |
| Time of maximum observed plasma concentration (Tmax) of metabolite | Up to 11 days |
| Terminal elimination half-life (T-HALF) of metabolite derived from plasma concentration | Up to 11 days |
| Metabolite-to-parent (MR) ratio for cMax | Up to 11 days |
| Metabolite-to-parent (MR) ratio for AUC(0-T) | Up to 11 days |
| Metabolite-to-parent (MR) ratio for AUC(0-72) | Up to 11 days |
| Metabolite-to-parent (MR) ratio for AUC(INF) | Up to 11 days |
| Number of clinically significant changes in vital signs, ECGs, physical examinations, or clinical laboratory tests | Up to 11 days |
Countries
United States
Outcome results
None listed