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Completed

NCT Number: NCT06851871

A Study to Evaluate the Bioequivalence Between Immediate Release Tablets and Minitablets of Deucravacitinib (BMS-986165), and the Effect of Food and pH on the Drug Levels of the Minitablets in Healthy Adults

The purpose of this study is to evaluate the bioequivalence between immediate release tablets and minitablets of Deucravacitinib (BMS-986165), and the effect of food and pH on the drug levels of the minitablets in healthy adults.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants must be healthy as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations in the opinion of the investigator.
  • Participants must be willing and able to complete all study-specific procedures and visits.
  • Participants must have a body mass index of 18.0 kg/m2 through 32.0 kg/m2, inclusive, and total body weight ≥ 50 kg (110 lb).

Exclusion criteria

  • Participants must not have any significant acute or chronic medical illness that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of/or acute liver disease in the opinion of the Investigator.
  • Participants must not have evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory determinations beyond what is consistent with the population reference ranges in the opinion of the investigator.
  • Participants must not have any history of severe reaction to a drug (eg, anaphylactic, anaphylactoid, Stevens-Johnson, angioedematous), or adverse or allergic/hypersensitivity reaction to multiple drugs.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Treatment and study plan

Deucravacitinib

Drug

Specified dose on specified days

Famotidine

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to day 20

  2. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

    Time frame: Up to day 20

  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

    Time frame: Up to day 20

Secondary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Up to day 44

  2. Incidence of serious adverse events (SAEs)

    Time frame: Up to day 44

  3. Incidence of AEs leading to discontinuation

    Time frame: Up to day 44

  4. Number of participants with a clinically significant change from baseline in vital signs

    Time frame: Up to day 21

  5. Number of participants with a change from baseline in 12-lead ECG results

    Time frame: Up to day 21

  6. Number of participants with physical examination abnormalities

    Time frame: Up to day 21

    A physical examination includes the assessment of the following: head, eyes, ears, nose, and throat (HEENT), cardiovascular (including peripheral vascular), lungs, abdomen, dermatological, and a general neurological examination

  7. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to day 20

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

    Time frame: Up to day 20

  9. Apparent total body clearance (CLT/F)

    Time frame: Up to day 20

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1, Open-label, Single-dose Study in Healthy Adult Participants to Assess the Bioequivalence Between Immediate Release Tablets and Minitablets, and to Assess the Food and pH Effect on the Pharmacokinetics of Deucravacitinib (BMS-986165) Administered as Minitablets

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2025
Registry last updated
Apr 29, 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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