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A Study to Assess the Drug Levels of CC-92480 After Coadministration With Rifampin and Itraconazole, and the Drug Levels of Digoxin and Rosuvastatin After Coadministration With CC-92480 in Healthy Participants

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05389722
Collaborator
(none)
48
Enrollment
3
Arms
4.3
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the drug levels of CC-92480 after coadministration with rifampin and itraconazole and the drug levels of digoxin and rosuvastatin after coadministration with CC-92480 in healthy participants.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Parallel-group, 3-part, 2-period, Fixed-sequence, Crossover, Open-label, Nonrandomized, Drug-drug Interaction Study to Assess the Pharmacokinetics of CC-92480 (BMS-986348) After Coadministration With Rifampin and Itraconazole, and Pharmacokinetics of Digoxin and Rosuvastatin After Coadministration With CC-92480 in Healthy Participants
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Oct 11, 2022
Anticipated Study Completion Date :
Oct 11, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1

Drug: CC-92480
Specified dose on specified days
Other Names:
  • BMS-986348

    • Drug: Rifampin
    Specified dose on specified days
    Experimental: Part 2

    Drug: CC-92480
    Specified dose on specified days
    Other Names:
  • BMS-986348

    • Drug: Itraconazole
    Specified dose on specified days
    Experimental: Part 3

    Drug: CC-92480
    Specified dose on specified days
    Other Names:
  • BMS-986348

    • Drug: Digoxin
    Specified dose on specified days

    Drug: Rosuvastatin
    Specified dose on specified days

    Outcome Measures

    Primary Outcome Measures

    1. Maximum observed plasma concentration (Cmax) [Up to 2 months]

    2. Time of maximum observed plasma concentration (Tmax) [Up to 2 months]

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

    Secondary Outcome Measures

    1. Number of participants with adverse events (AEs) [Up to 3 months]

    2. Number of participants with physical examination findings [Up to 3 months]

    3. Number of participants with vital sign abnormalities [Up to 3 months]

    4. Number of participants with 12-lead electrocardiogram (ECG) abnormalities [Up to 3 months]

    5. Number of participants with clinical laboratory abnormalities [Up to 3 months]

    Eligibility Criteria

    Criteria

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

    • Must have a body mass index between 18 and 33 kg/m2 (inclusive)

    • Adult female of nonchildbearing potential or male, any race or ethnicity, and in good health as determined by the medical history, physical exam, vital signs, 12-lead electrocardiogram, and clinical laboratory assessments

    Exclusion Criteria:

    • Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism, and excretion

    • Any major surgery within 4 weeks of the first dose administration

    • History of drug abuse within 2 years of the first dose administration

    Other protocol-defined inclusion/exclusion criteria apply

    Contacts and Locations

    Locations

    No locations specified.

    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:
    NCT05389722
    Other Study ID Numbers:
    • CA057-002
    First Posted:
    May 25, 2022
    Last Update Posted:
    May 25, 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
    CC-92480
    Healthy Volunteer
    Pharmacokinetic
    Additional relevant MeSH terms:
    Itraconazole
    Rifampin
    Digoxin
    Rosuvastatin Calcium

    Study Results

    No Results Posted as of May 25, 2022