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OpenTrials
Completed

NCT Number: NCT06566768

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

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Nottingham, Nottinghamshire, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Deucravacitinib

Drug

Specified dose on specified days

Other names: BMS-986165

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to approximately 5 days

  2. Concentration at 24 hours post dose (C24)

    Time frame: Up to approximately 5 days

  3. Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]

    Time frame: Up to approximately 5 days

Secondary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Up to approximately 1 month

  2. Incidence of serious adverse events (SAEs)

    Time frame: Up to approximately 1 month

  3. Incidence of AEs leading to discontinuation

    Time frame: Up to approximately 1 month

  4. Incidence of participants with vital sign abnormalities

    Time frame: Up to approximately 1 month

  5. Incidence of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to approximately 1 month

  6. Incidence of participants with physical examinations abnormalities

    Time frame: Up to approximately 1 month

  7. Incidence of participants with clinical laboratory abnormalities

    Time frame: Up to approximately 1 month

  8. Time of maximum observed concentration (Tmax)

    Time frame: Up to approximately 5 days

  9. Apparent terminal plasma half-life (T-HALF)

    Time frame: Up to approximately 5 days

  10. Apparent total body clearance (CLT/F)

    Time frame: Up to approximately 5 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2024
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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