Status:
COMPLETED
A Study to Assess the Bioavailability and Effect of Food of BMS-986419 Immediate-release Tablet Formulation in Healthy Adult Participants
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the impact of the BMS-986419 new immediate release (IR) tablet formulation compared to the current enteric (DR) capsule formulation, and to assess the effect of ...
Eligibility Criteria
Inclusion
- Healthy male and female participants without clinically significant deviation from normal, as determined by the investigator, in medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations.
- Body mass index (BMI) of 18.0 to 32.0 kilograms per meter squared (kg/m\^2), inclusive, and body weight ≥ 50 kg.
- A female participant is eligible to participate if she is a woman not of childbearing potential (WNOCBP)
Exclusion
- Any significant acute or chronic medical illness (eg, history of intracranial or intraspinal hemorrhage, CNS lesions, recent bacterial or fungal meningitis, etcetera) as determined by the investigator.
- Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could affect the absorption, distribution, metabolism, and excretion of study intervention (for example, bariatric procedure).
- History of Gilbert's syndrome.
- Women who are of childbearing potential and women who are breastfeeding.
Key Trial Info
Start Date :
August 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05963932
Start Date
August 8 2023
End Date
October 17 2023
Last Update
January 23 2024
Active Locations (1)
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1
Anaheim Clinical Trials
Anaheim, California, United States, 92801