Study to Evaluate Drug Levels of Various Solid Gastro-retentive Formulations of Deucravacitinib (BMS-986165) in Healthy Participants
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
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2024
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2024
CompletedFirst Posted
Study publicly available on registry
August 22, 2024
CompletedStudy Start
First participant enrolled
October 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 13, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 13, 2025
CompletedJuly 2, 2025
June 1, 2025
8 months
August 21, 2024
June 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Maximum observed plasma concentration (Cmax)
Up to approximately 5 days
Concentration at 24 hours post dose (C24)
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 Outcomes (10)
Incidence of adverse events (AEs)
Up to approximately 1 month
Incidence of serious adverse events (SAEs)
Up to approximately 1 month
Incidence of AEs leading to discontinuation
Up to approximately 1 month
Incidence of participants with vital sign abnormalities
Up to approximately 1 month
Incidence of participants with electrocardiogram (ECG) abnormalities
Up to approximately 1 month
- +5 more secondary outcomes
Study Arms (2)
Part A: Deucravacitinib
EXPERIMENTALPart B: Deucravacitinib
EXPERIMENTALInterventions
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution - 0001
Nottingham, Nottinghamshire, NG11 6JS, United Kingdom
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2024
First Posted
August 22, 2024
Study Start
October 7, 2024
Primary Completion
June 13, 2025
Study Completion
June 13, 2025
Last Updated
July 2, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and research/disclosurecommitment.html