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Clinical Trials in the USA / NCT07887763
Starting soon Phase 1

A Phase 1 Study to Evaluate Safety, Tolerability, and Drug Levels of BMS-986485 in Healthy Adult Participants

NCT07887763 · tracked via the Priya Life Science USA tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 1
Started
2026-11-03
Last updated
2026-10-21

Condition(s) studied

Healthy Volunteers

Investigational drug(s) / intervention(s)

BMS-986485BMS-986485 matching placebo

BMS-986485: Specified dose on specified days

BMS-986485 matching placebo: Specified dose on specified days

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Local Institution - 0001 Salt Lake City Utah

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07887763 on ClinicalTrials.gov ↗ ← All trials in the USA