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Completed

NCT Number: NCT05389722

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

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.

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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

Covance Clinical Research Unit - Dallas

Dallas, Texas, 75247-4968, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

CC-92480

Drug

Specified dose on specified days

Other names: BMS-986348

Rifampin

Drug

Specified dose on specified days

Itraconazole

Drug

Specified dose on specified days

Digoxin

Drug

Specified dose on specified days

Rosuvastatin

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 2 months

  2. Time of maximum observed plasma concentration (Tmax)

    Time frame: 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))

    Time frame: Up to 2 months

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 3 months

  2. Number of participants with physical examination findings

    Time frame: Up to 3 months

  3. Number of participants with vital sign abnormalities

    Time frame: Up to 3 months

  4. Number of participants with 12-lead electrocardiogram (ECG) abnormalities

    Time frame: Up to 3 months

  5. Number of participants with clinical laboratory abnormalities

    Time frame: Up to 3 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 25, 2022
Registry last updated
Apr 19, 2023

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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