Status:
COMPLETED
A Study to Evaluate the Drug Exposure of Single Ascending Doses of BMS-986369 and the Effect of Food on the BMS-986369 in Healthy Participants
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, drug levels of BMS-986369 following administration of single ascending oral doses (SAD) in healthy adult participants. The study will...
Eligibility Criteria
Inclusion
- Body mass index (BMI) 18.0 to 33.0 kg/m2, inclusive. BMI = weight (kg)/(height \[m\])2 for participants
- Must have a normal or clinically-acceptable 12-lead ECG at screening
- Absolute neutrophil counts must be greater than 2,500/μL at screening and Day -1
Exclusion
- Any significant acute or chronic medical illness that presents a potential risk to the participant in the opinion of the investigator and/or may compromise the objectives of the study
- History of clinically significant endocrine, gastrointestinal (GI), cardiovascular (CV), peripheral vascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary (GU) abnormalities/diseases
- History of major surgery within 8 weeks before the first dose administration
- Other protocol-defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
September 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2023
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT05350800
Start Date
September 12 2022
End Date
May 4 2023
Last Update
July 5 2024
Active Locations (1)
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1
Local Institution - 0001
Miami, Florida, United States, 33136