A Single-dose Study to Evaluate the Safety, Tolerability, Drug Levels, and Relative Biological Availability of Alternate Formulations of BMS-986460 in Healthy Adult Male Participants
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
85actual
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-03-19 | actual | When the study began enrolling |
| Primary completion | 2025-12-17 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-12-17 | actual | The whole study's end, after follow-up |
| First posted | 2025-03-14 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-01-20 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy Volunteers
Intervention
- Drug: BMS-986460
Primary outcomes
what the primary-completion date above is the date OFPart 1: Number of Participants With Adverse Events (AEs)
measured Up to approximately Day 43
Part 1: Number of Participants With Serious AEs (SAEs)
measured Up to approximately Day 43
Part 1: Number of Participants With Clinically Significant Physical Evaluation (PE) Findings
measured Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant Vital Sign Abnormalities
measured Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
measured Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings
measured Up to approximately Day 21
Part 1: Maximum Observed Plasma Concentration (Cmax) of BMS-986460
measured Up to approximately Day 21
Part 1: Time of Maximum Plasma Observed Concentration (Tmax) of BMS-986460
measured Up to approximately Day 21
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC [0-T]) of BMS-986460
measured Up to approximately Day 21
Part 1: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-986460
measured Up to approximately Day 21
Part 1: Relative Bioavailability (rBA) of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on Geometric Mean Ratio (GMR) of Cmax
measured Up to approximately Day 21
Part 1: rBA of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on GMR of AUC(0-T)
measured Up to approximately Day 21
Part 1: rBA of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on GMR of AUC(INF)
measured Up to approximately Day 21
Part 2: Number of Participants With AEs
measured Up to approximately Day 29
Part 2: Number of Participants With SAEs
measured Up to approximately Day 29
Part 2: Number of Participants With Clinically Significant PE Findings
measured Up to approximately Day 7
Part 2: Number of Participants With Clinically Significant Vital Sign Abnormalities
measured Up to approximately Day 7
Part 2: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
measured Up to approximately Day 7
Part 2: Number of Participants With Clinically Significant 12-lead ECG Findings
measured Up to approximately Day 7
Part 2: Cmax of BMS-986460
measured Up to approximately Day 7
Part 2: Tmax of BMS-986460
measured Up to approximately Day 7
Part 2: AUC [0-T] of BMS-986460
measured Up to approximately Day 7
Part 2: AUC(INF) of BMS-986460
measured Up to approximately Day 7
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