A Study to Assess the Effect of Itraconazole, Phenytoin and Gemfibrozil on the Drug Levels of BMS-986166 in Healthy Participants

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT04956627
Collaborator
(none)
15
1
4
9
1.7

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effect of itraconazole, phenytoin and gemfibrozil on the drug levels of BMS-986166 and its active metabolite BMT-121795. Participants will be randomly assigned to one of four groups and will remain in the study clinic for the duration of treatment.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Phase 1, Single-Center, Parallel-Group, Open-Label, Randomized, Drug-Drug Interaction Study to Assess the Effect of Itraconazole, Phenytoin, and Gemfibrozil on the Pharmacokinetics of a Single Oral Dose of BMS-986166 in Healthy Participants
Actual Study Start Date :
Jul 28, 2021
Actual Primary Completion Date :
Apr 27, 2022
Actual Study Completion Date :
Apr 27, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: BMS-986166

Drug: BMS-986166
Specified dose on specified days

Experimental: BMS-986166 + Itraconazole

Drug: BMS-986166
Specified dose on specified days

Drug: Itraconazole
Specified dose on specified days
Other Names:
  • Sporanox
  • Experimental: BMS-986166 + Phenytoin

    Drug: BMS-986166
    Specified dose on specified days

    Drug: Extended Phenytoin Sodium
    Specified dose on specified days
    Other Names:
  • Dilantin
  • Experimental: BMS-986166 + Gemfibrozil

    Drug: BMS-986166
    Specified dose on specified days

    Drug: Gemfibrozil
    Specified dose on specified days
    Other Names:
  • Lopid
  • Outcome Measures

    Primary Outcome Measures

    1. Maximum observed plasma concentration (Cmax) of BMS-986166 [Up to Day 22]

    2. Cmax of BMT-121795 [Up to Day 22]

    3. Time of maximum observed plasma concentration (Tmax) of BMS-986166 [Up to Day 22]

    4. Tmax of BMT-121795 [Up to Day 22]

    5. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986166 [Up to Day 22]

    6. AUC(0-T) of BMT-121795 [Up to Day 22]

    7. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))of BMS-986166 [Up to Day 22]

    8. AUC(INF) of BMT-121795 [Up to Day 22]

    9. Terminal plasma half-life (T-HALF) of BMS-986166 [Up to Day 22]

    10. T-HALF of BMT-121795 [Up to Day 22]

    11. Apparent total body clearance (CL/F) of BMS-986166 [Up to Day 22]

    12. Apparent volume of distribution (Vz/F) of BMS-986166 [Up to Day 22]

    13. Ratio of BMT-121795 Cmax to parent Cmax corrected for molecular weight (MR_Cmax) [Up to Day 22]

    14. Ratio of BMT-121795 AUC(0-T) to parent AUC(0-T) corrected for molecular weight (MR_AUC(0-T)) [Up to Day 22]

    15. Ratio of BMT-121795 AUC(INF) to parent AUC(INF) corrected for molecular weight (MR_AUC(INF)) [Up to Day 22]

    Secondary Outcome Measures

    1. Number of participants with Adverse Events (AEs) [Up to Day 55]

    2. Number of participants with Serious Adverse Events (SAEs) [Up to Day 55]

    3. Number of participants with physical examination abnormalities [Up to Day 55]

    4. Number of participants with clinically significant changes in vital signs: Body temperature [Up to Day 55]

    5. Number of participants with clinically significant changes in vital signs: Respiratory rate [Up to Day 55]

    6. Number of participants with clinically significant changes in vital signs: Blood pressure [Up to Day 55]

    7. Number of participants with clinically significant changes in vital signs: Heart rate [Up to Day 55]

    8. Number of participants with clinically significant changes in ECG parameters: PR interval [Up to Day 55]

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

    9. Number of participants with clinically significant changes in ECG parameters: QRS [Up to Day 55]

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

    10. Number of participants with clinically significant changes in ECG parameters: QT interval [Up to Day 55]

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

    11. Number of participants with clinically significant changes in ECG parameters: QTcF [Up to Day 55]

      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

    12. Number of participants with clinically significant changes in laboratory values: Hematology tests [Up to Day 55]

    13. Number of participants with clinically significant changes in laboratory values: Chemistry tests [Up to Day 55]

    14. Number of participants with clinically significant changes in laboratory values: Urinalysis [Up to Day 55]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Body weight of at least 55 kg.

    • Body mass index (BMI) of 19.0 to 32.0 kg/m², inclusive. BMI = weight (kg)/(height [m])².

    • Healthy female subjects of non-childbearing potential, or male subjects, as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations.

    Exclusion Criteria:
    • Any significant acute or chronic medical illness or any other condition listed as a contraindication in the itraconazole, phenytoin, or gemfibrozil package inserts.

    • History of any type of heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, symptomatic orthostatic hypotension, atrioventricular block of any degree, bradycardia, syncope, clinically significant 12-lead ECG abnormalities, or any congenital heart disease.

    • History of stroke or transient ischemic attacks.

    • History of asthma or chronic obstructive pulmonary disease diagnosed or treated within the past 5 years.

    Other protocol-defined inclusion/exclusion criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hassman Research Institute Berlin New Jersey United States 08009

    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:
    NCT04956627
    Other Study ID Numbers:
    • IM018-004
    First Posted:
    Jul 9, 2021
    Last Update Posted:
    May 13, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bristol-Myers Squibb
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 13, 2022