Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BMS-986231
HNO Donor · 7 trials · 12 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
The objective is to evaluate the effects of BMS-986231 on the left ventricular (LV) systolic function by stroke volume index (SVI) assessed by echocardiography compared to placebo.
Percentage of participants with clinically relevant hypotension, defined by systolic blood pressure (SBP) \< 90 mm Hg (confirmed by a repeated value \< 90 mm Hg) or symptoms of hypotension, up to 6 hours after the end of study drug infusion
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 |
| Placebo/BMS-986231/NTG | EXPERIMENTAL | administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods |
| Placebo/NTG/BMS-986231 | EXPERIMENTAL | administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods |
| NTG/Placebo/BMS-986231 | EXPERIMENTAL | administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods |
| NTG/BMS-986231/Placebo | EXPERIMENTAL | administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods |
| BMS-986231/Placebo/NTG | EXPERIMENTAL | administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods |
| BMS-986231/NTG/Placebo | EXPERIMENTAL | administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods |
| Part 1 Cohort 1 HNO Donor | EXPERIMENTAL | - |
| Placebo Part 1 Cohort 1 | PLACEBO_COMPARATOR | - |
| Part 2 Cohort 2 HNO Donor- low dose | EXPERIMENTAL | - |
| Part 2 Cohort 2 HNO Donor- high dose | EXPERIMENTAL | - |
| Placebo Part 2 Cohort 2 | PLACEBO_COMPARATOR | - |
| 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 |
| HNO Donor | DRUG | Infusion |
| Nitroglycerin (NTG) | DRUG | Infusion |
| 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...
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HNO Donor is an investigational small molecule being studied for the treatment of heart failure. It is a nitroxyl donor that has been evaluated in hospitalized patients with heart failure and in patients with heart failure and impaired systolic function. The drug is currently in Phase 2 clinical development.
HNO Donor is a nitroxyl (HNO) donor, meaning it releases nitroxyl, a reactive nitrogen species that can modulate cardiac function. Nitroxyl is believed to enhance myocardial contractility and vasodilation, which may be beneficial in heart failure. The drug is being developed to address reduced cardiac output and related symptoms.
HNO Donor is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for heart failure.
HNO Donor is in Phase 2 clinical development. It has completed two Phase 2 trials, with a total of 378 participants enrolled. The drug is not yet approved and remains investigational, meaning it has not been authorized for commercial use by regulatory authorities.
HNO Donor has been studied in two completed Phase 2 trials. The first, NCT03016325, evaluated 48-hour infusions in 329 hospitalized patients with heart failure. The second, NCT03357731, studied continuous infusions in 49 patients with heart failure and impaired systolic function. Both trials were randomized, double-blind, and controlled.
HNO Donor is a nitroxyl donor, not nitroxyl itself. It is a compound that releases nitroxyl (HNO) in the body. The drug is designed to deliver nitroxyl to exert its effects on the cardiovascular system, particularly in heart failure. It is not referred to by any other name in the available data.