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Completed

NCT Number: NCT04536961

A Study to Evaluate the Drug Levels of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants

The purpose of this study is to evaluate the drug levels of BMS-986165 in when taken by mouth as various solid tablet prototypes, by healthy participants.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences Miami

Nottingham, NG11 6JS, United Kingdom

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

  • No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (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). BMI = weight (kg)/(height [m])2 at screening.
  • Willing and able to consume 4 units of alcohol (Part B only)
  • A negative polymerase chain reaction (PCR) test for coronavirus disease 2019 (COVID-19) at screening and admission
  • Males and females must agree to follow specific methods of contraception, if applicable

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

Reference Treatment- BMS-986165-01

Drug

Specified dose on specified days

Other names: Deucravacitinib

Prototype BMS-986165

Drug

Specified dose on specified days

Other names: Deucravacitinib

Famotidine

Drug

Specified dose on specified days

Alcohol

Other

Specified quantity on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) of BMS-986165

    Time frame: Day 1 and Day 7

  2. Time of maximum observed plasma concentration (Tmax) of BMS-986165

    Time frame: Day 1 and Day 7

  3. Area under the plasma concentration-time curve from time zero to t (AUC (0-t)) of BMS-986165

    Time frame: Day 1 and Day 7

    Part A, B, C

Secondary outcomes

  1. Incidence of Nonserious Adverse Events (AEs)

    Time frame: Up to approximately 60 days (for Parts A & C), approximately 69 days (for Part B)

  2. Incidence of Serious Adverse Events (AEs)

    Time frame: Up to approximately 83 days (for Parts A & C), approximately 92 days (for Part B)

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

    Time frame: Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)

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

    Time frame: Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)

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

    Time frame: Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)

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

    Time frame: Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)

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

    Time frame: Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)

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

    Time frame: Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)

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

    Time frame: Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)

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

    Time frame: Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)

    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.

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

    Time frame: Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)

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

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

    Time frame: Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)

    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 electrocardiogram (ECG) parameters: PR interval

    Time frame: Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)

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

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 BMS-986165 Administered as Various Prototypic Solid Tablet Formulations in Healthy Subjects

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 3, 2020
Registry last updated
Oct 6, 2021

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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