Study to Evaluate Drug Levels of Various Solid Gastro-retentive Formulations of Deucravacitinib (BMS-986165) in Healthy Participants
- Registration Number
- NCT06566768
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to identify drug levels of gastro-retentive (GR) formulations which prolong retaining time in the stomach of deucravacitinib (BMS-986165) in Healthy Participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 52
Inclusion Criteria
- Healthy males and healthy females according to the assessment of the Investigator.
- Body mass index of 18.0 kg/m^2 through 32.0 kg/m^2, inclusive, and body weight ≥ 50 kg.
Exclusion Criteria
- Any significant acute or chronic medical illness.
- Current or recent (within 3 months of first dose) gastrointestinal (GI) disease that could possibly affect drug absorption, distribution, metabolism, and excretion.
- History of any significant drug allergy.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A: Deucravacitinib Deucravacitinib - Part B: Deucravacitinib Deucravacitinib -
- Primary Outcome Measures
Name Time Method Concentration at 24 hours post dose (C24) Up to approximately 5 days Maximum observed plasma concentration (Cmax) Up to approximately 5 days Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] Up to approximately 5 days
- Secondary Outcome Measures
Name Time Method Incidence of participants with vital sign abnormalities Up to approximately 1 month Time of maximum observed concentration (Tmax) Up to approximately 5 days Incidence of AEs leading to discontinuation Up to approximately 1 month Incidence of adverse events (AEs) Up to approximately 1 month Apparent terminal plasma half-life (T-HALF) Up to approximately 5 days Incidence of serious adverse events (SAEs) Up to approximately 1 month Incidence of participants with physical examinations abnormalities Up to approximately 1 month Incidence of participants with electrocardiogram (ECG) abnormalities Up to approximately 1 month Incidence of participants with clinical laboratory abnormalities Up to approximately 1 month Apparent total body clearance (CLT/F) Up to approximately 5 days
Trial Locations
- Locations (2)
Local Institution - 0002
🇬🇧Nottingham, Nottinghamshire, United Kingdom
Quotient Sciences
🇬🇧Nottingham, Nottinghamshire, United Kingdom