Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: pharmacokinetics
BMS-986369
CC-99282
healthy
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2024-04-12
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to Day 67
measure: Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
timeFrame: Up to Day 67
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
timeFrame: Up to Day 67
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to Day 69
measure: Number of participants with physical exam abnormalities
timeFrame: Up to Day 69
measure: Number of participants with vital sign abnormalities
timeFrame: Up to Day 69
measure: Number of participants with clinical laboratory safety test abnormalities
timeFrame: Up to Day 69
measure: Number of participants with electrocardiogram abnormalities
timeFrame: Up to Day 69
measure: Number of participants with concomitant medications
timeFrame: Up to Day 69
measure: Number of participants with concomitant procedures
timeFrame: Up to Day 69
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to Day 67
measure: Apparent terminal phase half-life (T-HALF)
timeFrame: Up to Day 67
measure: Apparent total body clearance (CLT/F)
timeFrame: Up to Day 67
measure: Apparent volume of distribution (Vz/F)
timeFrame: Up to Day 67
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Local Institution - 0002
state: Georgia
city: Lenexa
country: United States
facility: Local Institution - 0001
state: Kansas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: