A Study to Assess Drug Levels, Tolerability and Absolute Biological Availability of Single-dose of BMS-986446 in Healthy Participants
← catalyst calendarSponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →.
Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
46actual
Sites
2
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 | 2025-05-05 | actual | When the study began enrolling |
| Primary completion | 2025-09-11 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-09-11 | actual | The whole study's end, after follow-up |
| First posted | 2025-05-02 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-10-01 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy Volunteer
Interventions
- Drug: BMS-986446 IV
- Drug: BMS-986446 SC
- Drug: Acetaminophen
- Drug: Loratadine
Primary outcomes
what the primary-completion date above is the date OFGeometric Mean Ratio (GMR) of Maximum Observed Serum Concentration (Cmax) of BMS-986446 Administered IV versus SC
measured Up to approximately Day 85
GMR of Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of BMS-986446 Administered IV versus SC
measured Up to approximately Day 85
GMR of Area Under the Serum Concentration-time Curve From Time Zero to 672 Hours (AUC(0-672)) of BMS-986446 Administered IV versus SC
measured Up to approximately Day 85
Absolute Bioavailability (F) Estimated From GMR of AUC(INF) of BMS-986446 Administered as SC versus IV Infusion
measured Up to approximately Day 85
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