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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT04536961
Collaborator
(none)
56
Enrollment
1
Location
9
Arms
3.5
Actual Duration (Months)
16.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Reference Treatment- BMS-986165-01
  • Drug: Prototype BMS-986165
  • Drug: Famotidine
  • Other: Alcohol
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Sep 10, 2020
Actual Primary Completion Date :
Dec 25, 2020
Actual Study Completion Date :
Dec 25, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part A: Reference Treatment

Drug: Reference Treatment- BMS-986165-01
Specified dose on specified days
Other Names:
  • Deucravacitinib

    		•
    Experimental: Part A Prototype

    Drug: Prototype BMS-986165
    Specified dose on specified days
    Other Names:
  • Deucravacitinib

    		•
    Experimental: Part C Reference Treatment

    Drug: Reference Treatment- BMS-986165-01
    Specified dose on specified days
    Other Names:
  • Deucravacitinib

    		•
    Experimental: Part C: Prototype

    Drug: Prototype BMS-986165
    Specified dose on specified days
    Other Names:
  • Deucravacitinib

    		•
    Experimental: Part B: Treatment 1

    Drug: Prototype BMS-986165
    Specified dose on specified days
    Other Names:
  • Deucravacitinib

    		•
    Experimental: Part B: Treatment 2

    Drug: Prototype BMS-986165
    Specified dose on specified days
    Other Names:
  • Deucravacitinib

    		•
    Experimental: Part B: Treatment 3

    Drug: Prototype BMS-986165
    Specified dose on specified days
    Other Names:
  • Deucravacitinib

    		•
    Experimental: Part B: Treatment 4

    Drug: Prototype BMS-986165
    Specified dose on specified days
    Other Names:
  • Deucravacitinib

    • Drug: Famotidine
    Specified dose on specified days
    Experimental: Part B: Treatment 5

    Drug: Prototype BMS-986165
    Specified dose on specified days
    Other Names:
  • Deucravacitinib

    • Other: Alcohol
    Specified quantity on specified days

    Outcome Measures

    Primary Outcome Measures

    1. Maximum observed plasma concentration (Cmax) of BMS-986165 [Day 1 and Day 7]

    2. Time of maximum observed plasma concentration (Tmax) of BMS-986165 [Day 1 and Day 7]

    3. Area under the plasma concentration-time curve from time zero to t (AUC (0-t)) of BMS-986165 [Day 1 and Day 7]

      Part A, B, C

    Secondary Outcome Measures

    1. Incidence of Nonserious Adverse Events (AEs) [Up to approximately 60 days (for Parts A & C), approximately 69 days (for Part B)]

    2. Incidence of Serious Adverse Events (AEs) [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Quotient Sciences Miami Nottingham United Kingdom NG11 6JS

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT04536961
    Other Study ID Numbers:
    • IM011-136
    First Posted:
    Sep 3, 2020
    Last Update Posted:
    Oct 6, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Bristol-Myers Squibb
    Healthy volunteers
    Additional relevant MeSH terms:
    BMS-986165
    Famotidine

    Study Results

    No Results Posted as of Oct 6, 2021