Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03891108 | A Pharmacokinetics, Safety and Tolerability Study of Multiple Formulations of BMS-986231 in Healthy Participants | PHASE1 | COMPLETED | 60 | — | — | Feb 28, 2019 | Jul 29, 2019 | Oct 1, 2019 | 1 | United States |
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...