Clinical trial NCT06566768: Study to Evaluate Drug Levels of Various Solid Gastro-retentive Formulations of Deucravacitinib (BMS-986165) in Healthy Participants
Official title: A Phase 1, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Deucravacitinib (BMS-986165) Administered as Various Solid Oral Gastro-retentive Tablet Formulation Prototypes in Healthy Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Deucravacitinib
BMS-986165
Healthy volunteers
Single-dose
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-08-22
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to approximately 5 days
measure: Concentration at 24 hours post dose (C24)
timeFrame: Up to approximately 5 days
measure: Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
timeFrame: Up to approximately 5 days
Secondary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to approximately 1 month
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to approximately 1 month
measure: Incidence of AEs leading to discontinuation
timeFrame: Up to approximately 1 month
measure: Incidence of participants with vital sign abnormalities
timeFrame: Up to approximately 1 month
measure: Incidence of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to approximately 1 month
measure: Incidence of participants with physical examinations abnormalities
timeFrame: Up to approximately 1 month
measure: Incidence of participants with clinical laboratory abnormalities
timeFrame: Up to approximately 1 month
measure: Time of maximum observed concentration (Tmax)
timeFrame: Up to approximately 5 days
measure: Apparent terminal plasma half-life (T-HALF)
timeFrame: Up to approximately 5 days
measure: Apparent total body clearance (CLT/F)
timeFrame: Up to approximately 5 days
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Local Institution - 0002
state: Nottinghamshire
city: Nottingham
country: United Kingdom
facility: Quotient Sciences
state: Nottinghamshire
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: