Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMS-986231 · 5 trials · 10 indications
The total volume of urinary output 4 hours after 40 mg furosemide bolus given to participants with HFrEF while on BMS-986231 compared to placebo: absolute difference in total volume and % change from placebo. Sequence 1: Placebo in period 1, drug in period 2 Sequence 2: Drug in period 1, placebo in period 2
Measured by plasma concentrations
Measured by plasma urine, feces, and vomit (if applicable) volumes and radioactivity counts
Measured by plasma concentrations
Measured by plasma concentrations
Measured by plasma concentrations
Measured by plasma concentrations
| Arm | Type | Description |
|---|---|---|
| Placebo+Diuretic to BMS-986231+Diuretic | EXPERIMENTAL | Administered in a cross over design with 8-hour continuous infusions and 7-28 day wash-out periods |
| BMS-986231+Diuretic to Placebo+Diuretic | EXPERIMENTAL | Administered in a cross over design with 8-hour continuous infusions and 7-28 day wash-out periods |
| Mild hepatic impairment | EXPERIMENTAL | Based on Hepatic Function Impairment - Child-Pugh A score 5 to 6 points |
| Moderate hepatic impairment | EXPERIMENTAL | Based on Hepatic Function Impairment - Child-Pugh B score 7 to 9 points |
| Severe hepatic impairment | EXPERIMENTAL | Based on Hepatic Function Impairment - Child-Pugh C score 10 to 15 points |
| Normal hepatic function | EXPERIMENTAL | Based on Hepatic Function Impairment as defined by the investigator |
| Mild Renal Impairment | EXPERIMENTAL | Mild renal impairment defined as eGFR 60 to \<90 mL/min/1.73 m\^2 |
| Moderate renal impairment | EXPERIMENTAL | Moderate renal impairment defined as eGFR 30 to \<60 mL/min/1.73 m\^2 |
| Severe renal impairment | EXPERIMENTAL | Severe renal impairment defined as eGFR \<30 mL/min/1.73 m\^2, not requiring dialysis |
| Normal renal function | EXPERIMENTAL | Normal renal function defined as eGFR ≥90 mL/min/1.73 m\^2 |
| BMS-986231 Intravenous Infusion | EXPERIMENTAL | A single continuous intravenous infusion of BMS-986231 |
| Panel 1 Arm | EXPERIMENTAL | BMS-986231 and BMS-986231 Placebo intravenously |
| Panel 2 Arm | EXPERIMENTAL | BMS-986231 and BMS-986231 Placebo intravenously |
| Panel 3 Arm | EXPERIMENTAL | BMS-986231 and BMS-986231 Placebo intravenously |
| Name | Type | Description |
|---|---|---|
| BMS-986231 | DRUG | Intravenous administration |
| Furosemide | DRUG | Intravenous administration |
| Placebo | DRUG | Intravenous administration |
| BMS-986231 Placebo | DRUG | - |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Left ventricular ejection fraction \<45%, as assessed by echocardiography, a multigated acquisition (MUGA) scan or magnetic resonance imaging (MRI) scan with...
BMS-986231 is an investigational small molecule being studied for cardiovascular conditions, including acute heart decompensation, cardiac failure, myocardial failure, and liver dysfunction. It is in Phase 2 clinical development and has not been approved by the FDA.
BMS-986231 is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with heart failure and related conditions.
BMS-986231 is in Phase 2 clinical development. It has completed two Phase 1 trials and one Phase 2 trial, with no active trials currently ongoing. The drug remains investigational and is not yet approved for any use.
BMS-986231 has been studied in several completed trials. NCT02932969 and NCT03210909 were Phase 1 studies in healthy volunteers. NCT03515980 examined liver function effects, and NCT03730961 was a Phase 2 trial in heart failure patients receiving a loop diuretic.
BMS-986231 is the sole name provided for this investigational compound. No alternative names or brand names have been associated with it in the clinical trial records. It is identified only by its development code BMS-986231.