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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Deucravacitinib

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG11 6JS
      • Local Institution - 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: Deucravacitinib	Drug: Deucravacitinib; Specified dose on specified days; Other Names: BMS-986165
Experimental: Part B: Deucravacitinib	Drug: Deucravacitinib; Specified dose on specified days; Other Names: BMS-986165

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Incidence of participants with physical examinations abnormalities	Up to approximately 1 month
Incidence of participants with clinical laboratory abnormalities	Up to approximately 1 month
Time of maximum observed concentration (Tmax)	Up to approximately 5 days
Apparent terminal plasma half-life (T-HALF)	Up to approximately 5 days
Apparent total body clearance (CLT/F)	Up to approximately 5 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2024
• Primary Completion (Actual): June 13, 2025
• Study Completion (Actual): June 13, 2025

Study Registration Dates

• First Submitted: August 21, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Healthy volunteers; Deucravacitinib; BMS-986165; Single-dose
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dermatologic Agents; Protein Kinase Inhibitors; Deucravacitinib
• Other Study ID Numbers: IM011-1201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes