Heart Decompensation, Acute
Conditions
Brief summary
An intravenous infusion in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986231
Interventions
DRUGBMS-986231
BMS-986231
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed Informed Consent * Target population: Healthy males with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests * Body weight between 75 and 95 kg, inclusive; body mass index (BMI) between 18 to 32 kg/m2.
Exclusion criteria
* History of chronic illness * Chronic headaches * Recurrent dizziness * Personal or family history of heart disease * Personal history of bleeding diathesis Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume of Distribution during Terminal Elimination Phase (Vz/F) | Up to 8 days | Measured by plasma concentrations |
| Area Under the Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T]) | Up to 8 days | Measured by plasma concentrations |
| Percent of Total Radioactivity Recovered in All Excreta (% total) | Up to 8 days | Measured by plasma urine, feces, and vomit (if applicable) volumes and radioactivity counts |
| Half-Life (T-HALF) | Up to 8 days | Measured by plasma concentrations |
| Total Body Clearance (CLT) | Up to 8 days | Measured by plasma concentrations |
| Time to Maximum Observed Concentration (Tmax) | Up to 8 days | Measured by plasma concentrations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Results of electrocardiogram tests (ECGs) | Up to 8 days | Measured by investigator assessment |
| Results of vital sign measurements | Up to 8 days | Measured by investigator assessment |
| Results of clinical laboratory tests | Up to 8 days | Measured by investigator assessment |
| Incidence of adverse events (AEs) | Up to 8 days | Measured by investigator assessment |
Countries
United States
Outcome results
None listed