A Phase 1, Randomized, Double-Blind, Placebo-Controlled, First-in-Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of Orally Administered BMS-986485 in Healthy Adult Participants (Part A), and a Conditional Open-label Study to Evaluate the Relative Bioavailability of Alternate Formulations of BMS-986485 in Healthy Adult Participants (Part B)
| Registry | NCT07887763 |
|---|
| Status | Not yet recruiting |
|---|
| Phase | Phase 1 |
|---|
| Study type | Interventional; randomized, sequential, masking: quadruple, treatment |
|---|
| Enrollment | 50 (Estimated) |
|---|
| Sponsor | Bristol-Myers Squibb (Industry) |
|---|
| Conditions | Healthy Volunteers |
|---|
| Interventions | BMS-986485, BMS-986485 matching placebo (Drug, other) |
|---|
| Dates | start 2026-11-03 (estimated), primary completion 2027-06-08 (estimated), completion 2027-06-08 (estimated), first posted 2026-10-21, last updated 2026-10-21 |
|---|
| Locations | 1 site in United States |
|---|
Related Papers Related Patents Related Grants Related Experts
All trials for Healthy Volunteers All trials of BMS-986485 All trials of BMS-986485 matching placebo
-Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of the administration of a single ascending doses of BMS-986485 in healthy adult participants.
Expand all sections · Collapse all
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Part A: SAD | Experimental | Drug: BMS-986485; Other: BMS-986485 matching placebo | |
| Part B: Conditional rBA | Experimental | Drug: BMS-986485 | |
- BMS-986485 (Drug): Specified dose on specified days
- BMS-986485 matching placebo (Other): Specified dose on specified days
+Outcome measures
Primary outcomes
- Number of participants with Treatment Emergent Adverse Events (TEAEs) [Up to approximately Day 29]
- Number of participants with Serious Adverse Events (SAEs) [Up to approximately Day 29]
- Number of participants with Vital Signs abnormalities [Up to approximately Day 29]
- Number of participants with Physical Examination abnormalities [Up to approximately Day 29]
- Number of Participants with 12-Lead Electrocardiogram (ECG) abnormalities [Up to approximately Day 9]
- Number of Participants with Holter ECG abnormalities [Up to Day 2]: Part A
- Number of participants with Clinical Laboratory abnormalities [Up to approximately Day 29]
- Number of participants with suicidal ideation and behavior assessed by Columbia Suicide Severity Rating Scale (C-SSRS) [Up to Day 9]
- Time of maximum observed blood concentration (Tmax) [Up to Day 6]: Part B
- Maximum observed blood concentration (Cmax) [Up to Day 6]: Part B
- Apparent total body clearance (CL/F) [Up to Day 6]: Part B
- Apparent volume of distribution during the terminal phase (Vz/F) [Up to Day 6]: Part B
- Apparent Terminal Phase Half-life (T-HALF) [Up to Day 6]: Part B
- Geometric mean ratios (GMRs) of Cmax [Up to Day 6]: Part B
- GMRs of AUC(0-T) [Up to Day 6]: Part B
- GMRs of AUC(INF) [Up to Day 6]: Part B
- Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) [Up to Day 6]: Part B
- Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) [Up to Day 6]: Part B
Secondary outcomes
- Time of maximum observed blood concentration (Tmax) [Up to Day 7]
- Maximum observed blood concentration (Cmax) [Up to Day 7]
- Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) [Up to Day 7]
- Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) [Up to Day 7]
- Apparent total body clearance (CL/F) [Up to Day 7]
- Apparent volume of distribution during the terminal phase (Vz/F) [Up to Day 7]
- Apparent Terminal Phase Half-life (T-HALF) [Up to Day 7]
+Eligibility
Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers
Inclusion Criteria:
* Participants must have body mass index (BMI) range of 18 to 33 kg/m2.
Exclusion Criteria:
* Participants must not have any significant medical condition (including but, not limited to, neurological, GI, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders).
* Participants mut not have any major surgery or planned surgery (except GI surgery) within 12 weeks of study intervention administration.
* Participants mut not have history of neurological condition (including stroke, traumatic brain injury, intracranial or intraspinal bleeding, or major neurological disorders).
* Other protocol defined inclusion/exclusion criteria apply.
+Locations (1)
| Facility | City | Country | Status |
|---|
| Local Institution - 0001 | Salt Lake City, Utah | United States | |
+Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb