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OpenTrials
Completed

NCT Number: NCT04949269

A Study to Evaluate the Drug Levels of Deucravacitinib From Tablets After Oral Administration in Healthy Participants

The purpose of this study is to assess the drug levels of deucravacitinib after oral administration in healthy participants.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences Miami, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com

Inclusion criteria

  • Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations.
  • Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and total body weight ≥50 kg (110 lb).
  • Willing and able to consume 4 units of alcohol (Part C only). Only participants with low to moderate alcohol consumption will be enrolled in Part C of this study (ie, consumption of between 1 and 21 units per week for males and between 1 and 14 units per week in females).

Exclusion criteria

  • Current or recent (within 3 months or 90 days of study drug administration) clinically significant gastrointestinal disease that, in the opinion of the investigator or medical monitor, could impact upon the absorption of study drug.
  • Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease.
  • Clinically significant history or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months or 90 days prior to screening.

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

Deucravacitinib

Drug

Specified dose on specified days

Other names: BMS-986165

Famotidine

Drug

Specified dose on specified days

Other names: Pepcid

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of deucravacitinib

    Time frame: Up to 7 days

  2. Area Under the Concentration-time Curve from time 0 to 24 hours postdose (AUC(0-24)) of deucravacitinib

    Time frame: Up to 7 days

  3. Concentration at 24 hours of post-morning dose on Day 1 and Day 7 (C24) of deucravacitinib

    Time frame: Up to 7 days

Secondary outcomes

  1. Incidence of non-serious Adverse Events (AEs)

    Time frame: Up to 18 days

  2. Incidence of Serious Adverse Events (SAEs)

    Time frame: Up to 30 days post discontinuation of dosing or participant's participation in the study

  3. Incidence of clinically significant changes in clinical laboratory values: Hematology tests

    Time frame: Up to 11 days

  4. Incidence of clinically significant changes in clinical laboratory values: Chemistry tests

    Time frame: Up to 11 days

  5. Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests

    Time frame: Up to 11 days

  6. Incidence of clinically significant changes in vital signs: Body temperature

    Time frame: Up to 11 days

  7. Incidence of clinically significant changes in vital signs: Respiratory rate

    Time frame: Up to 11 days

  8. Incidence of clinically significant changes in vital signs: Blood pressure

    Time frame: Up to 11 days

  9. Incidence of clinically significant changes in vital signs: Heart rate

    Time frame: Up to 11 days

  10. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval

    Time frame: Up to 11 days

    PR interval is the time from the onset of the P wave to the start of the QRS complex

  11. Incidence of clinically significant changes in ECG parameters: QRS

    Time frame: Up to 11 days

    QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization

  12. Incidence of clinically significant changes in ECG parameters: QT interval

    Time frame: Up to 11 days

    The QT interval is the time from the start of the Q wave to the end of the T wave

  13. Incidence of clinically significant changes in ECG parameters: QTcF

    Time frame: Up to 11 days

    QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1, Open-label, Crossover Study to Evaluate the Pharmacokinetics of Deucravacitinib (BMS-986165) Administered as Various Solid Tablet Formulations in Healthy Subjects

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 2, 2021
Registry last updated
Mar 11, 2022

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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