Healthy Volunteers
Conditions
Keywords
pharmacokinetics, BMS-986369, CC-99282, healthy
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.
Interventions
DRUGItraconazole
Specified dose on specified days.
DRUGRifampin
Specified dose on specified days
DRUGGolcadomide
Specified dose on specified days
Sponsors
Celgene
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) | Up to Day 67 |
| Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) | Up to Day 67 |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Up to Day 67 |
Secondary
| Measure | Time frame |
|---|---|
| Apparent volume of distribution (Vz/F) | Up to Day 67 |
| Number of participants with adverse events (AEs) | Up to Day 69 |
| Number of participants with physical exam abnormalities | Up to Day 69 |
| Number of participants with vital sign abnormalities | Up to Day 69 |
| Time of maximum observed plasma concentration (Tmax) | Up to Day 67 |
| Number of participants with electrocardiogram abnormalities | Up to Day 69 |
| Number of participants with concomitant medications | Up to Day 69 |
| Number of participants with concomitant procedures | Up to Day 69 |
| Number of participants with clinical laboratory safety test abnormalities | Up to Day 69 |
| Apparent terminal phase half-life (T-HALF) | Up to Day 67 |
| Apparent total body clearance (CLT/F) | Up to Day 67 |
Countries
United States
Outcome results
None listed