Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986454 in Healthy Participants
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety and tolerability of BMS-986454 in healthy adult participants.
Eligibility Criteria
Inclusion
- Male and female participants who are healthy as determined by the investigator based on review of medical history, physical examinations, 12-lead ECGs, and clinical laboratory tests obtained during the screening period.
- Participant is willing and able to adhere to the study visit schedule and other protocol requirements.
- A negative test for COVID-19, which will be performed in the manner mandated by the clinical site where this study is being conducted, at screening and admission.
Exclusion
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory tests beyond what is consistent with a healthy population in the region in which the study is conducted.
- Participant was exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or 5 half-lives of that investigational drug, if known (whichever is longer).
- Inability to be venipunctured or tolerate venous access.
- Note: Other protocol-defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
November 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2024
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT06086886
Start Date
November 16 2023
End Date
December 20 2024
Last Update
March 24 2025
Active Locations (2)
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1
Local Institution - 0002
London, Greater London, United Kingdom, NW10 7EW
2
Local Institution - 0001
Nottingham, United Kingdom, NG11 6JS