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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06566768

Enrollment

Registered

2024-08-22

Start date

2024-10-07

Completion date

2025-06-13

Last updated

2025-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Keywords

Deucravacitinib, BMS-986165, Healthy volunteers, Single-dose

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.

Interventions

DRUGDeucravacitinib

Specified dose on specified days

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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/

Design outcomes

Primary

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

Measure	Time frame
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 adverse events (AEs)	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
Incidence of participants with clinical laboratory abnormalities	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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026