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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Specified dose on specified days.
Specified dose on specified days
Specified dose on specified days
Local Institution - 0002
Atlanta, Georgia, United States
Local Institution - 0001
Lenexa, Kansas, United States
Maximum observed plasma concentration (Cmax)
Time frame: Up to Day 67
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
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to Day 67
Number of participants with adverse events (AEs)
Time frame: Up to Day 69
Number of participants with physical exam abnormalities
Time frame: Up to Day 69
Number of participants with vital sign abnormalities
Time frame: Up to Day 69
Number of participants with clinical laboratory safety test abnormalities
Time frame: Up to Day 69
Number of participants with electrocardiogram abnormalities
Time frame: Up to Day 69
Number of participants with concomitant medications
Time frame: Up to Day 69
Number of participants with concomitant procedures
Time frame: Up to Day 69
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to Day 67
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Apparent terminal phase half-life (T-HALF)
Time frame: Up to Day 67
Apparent total body clearance (CLT/F)
Time frame: Up to Day 67
Apparent volume of distribution (Vz/F)
Time frame: Up to Day 67