A Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Drug Levels of Golcadomide (BMS-986369) in Healthy Participants

Last updated: September 26, 2024
Sponsor: Celgene
Overall Status: Completed

Phase

1

Condition

Healthy Volunteers

Treatment

Rifampin

Golcadomide

Itraconazole

Clinical Study ID

NCT06363630
CA073-1000
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to evaluate the drug-drug interaction (DDI) potential of coadministration of itraconazole or rifampin on the single dose drug levels of golcadomide.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy male and female non smoking participants, of any race, as determined by theinvestigator to have no clinically significant deviation from normal, in medicalhistory and physical examination which correspond to a condition that couldpotentially increase the risk for the participants, or jeopardize the integrity ofthe study data, in 12-lead ECG measurements, vital signs, and clinical laboratorydeterminations, at screening and at check-in.

  • Body mass index (BMI) 18.0 to 33.0 kg/m2, inclusive. BMI = weight (kg)/(height [m])2for participants.

  • Participant is afebrile (febrile is defined as ≥ 38°C or ≥ 100.4°F), with systolicblood pressure ≥ 90 and ≤ 140 mmHg, diastolic blood pressure ≥ 50 and ≤ 90 mmHg, andpulse rate ≥ 40 and ≤ 90 beats per minute at screening, confirmed by repeat, as perclinical site's standard.

  • Must have a normal or clinically acceptable 12-lead ECG at screening: Participantsmust have a corrected QT interval using QTcF value ≤ 450 msec.

  • Absolute neutrophil counts must be greater than 2,500/μL at screening and Day -1.

  • Must have adequate laboratory test results for renal and hepatic function asassessed by the PI (Principal Investigator). Laboratory testing may be repeated tofind all possible well-qualified participants.

Exclusion

Exclusion Criteria:

  • Any significant acute or chronic medical illness that presents a potential risk tothe participant in the opinion of the investigator and/or may compromise theobjectives of the study.

  • History of clinically significant endocrine, gastrointestinal (GI), cardiovascular (CV), peripheral vascular, hematological, hepatic, immunological, renal,respiratory, or genitourinary (GU) abnormalities/diseases.

  • Has any surgical or medical conditions possibly affecting drug absorption,distribution, metabolism and excretion (ADME). Appendectomy and cholecystectomy areacceptable. Prior procedures of unclear ADME significance should be reviewed withthe Sponsor's Medical Monitor.

  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Total Participants: 35
Treatment Group(s): 3
Primary Treatment: Rifampin
Phase: 1
Study Start date:
April 23, 2024
Estimated Completion Date:
August 29, 2024

Connect with a study center

  • CenExel CNS

    Atlanta, Georgia 30331
    United States

    Active - Recruiting

  • Local Institution - 0002

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • ICON Lenexa

    Lenexa, Kansas 66219
    United States

    Active - Recruiting

  • Local Institution - 0001

    Lenexa, Kansas 66219
    United States

    Site Not Available

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