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

Last updated: April 18, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

Deucravacitinib

Clinical Study ID

NCT06566768
IM011-1201
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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 ≥ 50kg.

Exclusion

Exclusion Criteria:

  • Any significant acute or chronic medical illness.

  • Current or recent (within 3 months of first dose) gastrointestinal (GI) disease thatcould possibly affect drug absorption, distribution, metabolism, and excretion.

  • History of any significant drug allergy.

  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Total Participants: 52
Treatment Group(s): 1
Primary Treatment: Deucravacitinib
Phase: 1
Study Start date:
October 07, 2024
Estimated Completion Date:
June 12, 2025

Connect with a study center

  • Local Institution - 0001

    Nottingham, Nottinghamshire NG11 6JS
    United Kingdom

    Site Not Available

  • Local Institution - 0002

    Nottingham, Nottinghamshire NG11 6JS
    United Kingdom

    Site Not Available

  • Quotient Sciences

    Nottingham, Nottinghamshire NG11 6JS
    United Kingdom

    Active - Recruiting

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