Study to Evaluate Drug Levels of Various Solid Gastro-retentive Formulations of Deucravacitinib (BMS-986165) in Healthy Participants
Phase 1
Not yet recruiting
- Conditions
- Healthy Participants
- Registration Number
- NCT06566768
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 52
Inclusion Criteria
Inclusion Criteria:<br><br> - Healthy males and healthy females according to the assessment of the Investigator.<br><br> - Body mass index of 18.0 kg/m^2 through 32.0 kg/m^2, inclusive, and body weight = 50<br> kg.<br><br>Exclusion Criteria:<br><br> - Any significant acute or chronic medical illness.<br><br> - Current or recent (within 3 months of first dose) gastrointestinal (GI) disease that<br> could possibly affect drug absorption, distribution, metabolism, and excretion.<br><br> - History of any significant drug allergy.<br><br> - Other protocol-defined Inclusion/Exclusion criteria apply.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax);Concentration at 24 hours post dose (C24);Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
- Secondary Outcome Measures
Name Time Method Incidence of adverse events (AEs);Incidence of serious adverse events (SAEs);Incidence of AEs leading to discontinuation;Incidence of participants with vital sign abnormalities;Incidence of participants with electrocardiogram (ECG) abnormalities;Incidence of participants with physical examinations abnormalities;Incidence of participants with clinical laboratory abnormalities;Time of maximum observed concentration (Tmax);Apparent terminal plasma half-life (T-HALF);Apparent total body clearance (CLT/F)