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Completed

NCT Number: NCT06363630

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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0002, Atlanta, Georgia, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male and female non smoking participants, of any race, as determined by the investigator to have no clinically significant deviation from normal, in medical history and physical examination which correspond to a condition that could potentially increase the risk for the participants, or jeopardize the integrity of the study data, in 12-lead ECG measurements, vital signs, and clinical laboratory determinations, at screening and at check-in.
  • Body mass index (BMI) 18.0 to 33.0 kg/m2, inclusive. BMI = weight (kg)/(height [m])2 for participants.
  • Participant is afebrile (febrile is defined as ≥ 38°C or ≥ 100.4°F), with systolic blood pressure ≥ 90 and ≤ 140 mmHg, diastolic blood pressure ≥ 50 and ≤ 90 mmHg, and pulse rate ≥ 40 and ≤ 90 beats per minute at screening, confirmed by repeat, as per clinical site's standard.
  • Must have a normal or clinically acceptable 12-lead ECG at screening: Participants must 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 as assessed by the PI (Principal Investigator). Laboratory testing may be repeated to find all possible well-qualified participants.

Exclusion criteria

  • Any significant acute or chronic medical illness that presents a potential risk to the participant in the opinion of the investigator and/or may compromise the objectives 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 are acceptable. Prior procedures of unclear ADME significance should be reviewed with the Sponsor's Medical Monitor.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Treatment and study plan

Itraconazole

Drug

Specified dose on specified days.

Rifampin

Drug

Specified dose on specified days

golcadomide

Drug

Specified dose on specified days

Other names: BMS-986369

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to Day 67

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

    Time frame: Up to Day 67

  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

    Time frame: Up to Day 67

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to Day 69

  2. Number of participants with physical exam abnormalities

    Time frame: Up to Day 69

  3. Number of participants with vital sign abnormalities

    Time frame: Up to Day 69

  4. Number of participants with clinical laboratory safety test abnormalities

    Time frame: Up to Day 69

  5. Number of participants with electrocardiogram abnormalities

    Time frame: Up to Day 69

  6. Number of participants with concomitant medications

    Time frame: Up to Day 69

  7. Number of participants with concomitant procedures

    Time frame: Up to Day 69

  8. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to Day 67

  9. Apparent terminal phase half-life (T-HALF)

    Time frame: Up to Day 67

  10. Apparent total body clearance (CLT/F)

    Time frame: Up to Day 67

  11. Apparent volume of distribution (Vz/F)

    Time frame: Up to Day 67

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

A Phase 1, Open-label, 2-part, 2-period, Fixed-sequence, Crossover Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Pharmacokinetics of Golcadomide (BMS-986369) in Healthy Participants

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 12, 2024
Registry last updated
Sep 27, 2024

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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