Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BMS-986231
CXL-1427 Ascending Dose · 6 trials · 11 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 |
| CXL-1427 (BMS-986231) | EXPERIMENTAL | Experimental |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| BMS-986231 | DRUG | Intravenous administration |
| Furosemide | DRUG | Intravenous administration |
| Placebo | DRUG | Intravenous administration |
| BMS-986231 Placebo | DRUG | - |
| CXL-1427 Ascending Dose | DRUG | - |
| CXL-1427 Descending Dose | 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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CXL-1427 is an investigational small molecule being studied for the treatment of Heart Failure. It is administered as a single continuous intravenous (IV) infusion for up to 48 hours. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
CXL-1427 is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company is conducting clinical trials to evaluate the safety of this investigational drug for Heart Failure.
CXL-1427 is in Phase 1 clinical development. A first-in-human study of the drug has been completed, evaluating the safety of single continuous intravenous infusions for up to 48 hours in healthy volunteers. The drug remains investigational and is not yet approved.
CXL-1427 has one completed Phase 1 clinical trial registered as NCT02819271. This first-in-human study assessed the safety of single continuous intravenous infusions of CXL-1427 for up to 48 hours in 80 healthy volunteers, with a placebo-controlled, randomized, double-blind design.
CXL-1427 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Heart Failure. The completed clinical trial focused on safety in healthy volunteers, and the drug has not yet progressed to later-stage studies or regulatory approval.