Study to Evaluate Drug Levels of Various Solid Gastro-retentive Formulations of Deucravacitinib (BMS-986165) in Healthy Participants

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Deucravacitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06566768

IM011-1201

Details and patient eligibility

About

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Part A: Deucravacitinib

Experimental group

Treatment:

Drug: Deucravacitinib

Part B: Deucravacitinib

Experimental group

Treatment:

Drug: Deucravacitinib