Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMS-986231 Formulation A · 1 trial · 1 indication
Cmax is the maximum plasma concentration.
Css-av is defined as the average concentration over a dosing interval.
AUC(INF) is defined as area under the plasma concentration-time curve from time 0 (dosing) extrapolated to infinity.
AUC(0-T) is defined as area under the concentration-time curve from time 0 (dosing) to the time of the last quantifiable concentration observed (T).
T-HALF is terminal elimination phase half-life.
Tmax is defined as time to reach Cmax in plasma.
MRAUC(INF) is determined using AUC(INF) for metabolite / AUC(INF) for BMS-986231. MRCss-av is determined using Css-av for metabolite / Css-av for BMS-986231.
CLT is total systemic clearance.
Vz is apparent volume of distribution during the terminal phase.
Vss is volume of distribution at steady state.
| Arm | Type | Description |
|---|---|---|
| Treatment A: BMS-986231 Formulation A | ACTIVE_COMPARATOR | Participants will be administered Treatment A: BMS-986231 Formulation A as a 48-hour IV infusion on Day 1, followed by review of safety and tolerability data during and after the infusion. |
| Treatment B: BMS-986231 Formulation B | EXPERIMENTAL | Participants will be administered Treatment B: BMS-986231 Formulation B as a 48-hour IV infusion on Day 1, followed by review of safety and tolerability data during and after the infusion. |
| Treatment C: BMS-986231 Formulation C | EXPERIMENTAL | Participants will be administered Treatment C: BMS-986231 Formulation C as a 48-hour IV infusion on Day 1, followed by review of safety and tolerability data during and after the infusion. |
| Treatment D: BMS 986231 Formulation D | EXPERIMENTAL | Participants will be administered Treatment D: BMS 986231 Formulation D as a 48-hour IV infusion on Day 1, followed by review of safety and tolerability data during and after the infusion. |
| Name | Type | Description |
|---|---|---|
| BMS-986231 Formulation A | DRUG | Participants will be administered BMS-986231 Formulation A as IV infusion for 48 hours. |
| BMS-986231 Formulation B | DRUG | Participants will be administered BMS-986231 Formulation B as IV infusion for 48 hours. |
| BMS-986231 Formulation C | DRUG | Participants will be administered BMS-986231 Formulation C as IV infusion for 48 hours. |
| BMS-986231 Formulation D | DRUG | Participants will be administered BMS-986231 Formulation D as IV infusion for 48 hours. |
Inclusion Criteria: * Participants must be willing to participate in the study and sign the informed consent form (ICF). * Participants must be willing and able to complete all study-specific procedures and visits. * Healthy participant, as determined by no clinically significant deviation from nor...
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BMS-986231 Formulation A is an investigational small molecule being developed for heart failure. It is currently in Phase 1 clinical development, meaning it has not been approved by regulatory authorities and is still being studied for safety and tolerability in clinical trials.
BMS-986231 Formulation A is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate this investigational drug for the treatment of heart failure.
BMS-986231 Formulation A is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied in early-stage trials to assess its pharmacokinetics, safety, and tolerability.
BMS-986231 Formulation A has one completed clinical trial registered under NCT03891108. This Phase 1 study evaluated the pharmacokinetics, safety, and tolerability of multiple formulations of BMS-986231 in healthy participants in the United States. The trial enrolled 60 participants and was active-controlled.
BMS-986231 Formulation A is a specific formulation of the investigational drug BMS-986231. The clinical trial NCT03891108 studied multiple formulations of BMS-986231, including Formulation A, to compare their pharmacokinetic profiles. This formulation is being developed for heart failure.