The purpose of the study is to assess the effects of multiple doses of itraconazole (a strong CYP3A4 inhibitor) on single dose PK of casdatifan in healthy adults and to assess the effects of multiple doses of phenytoin (a strong CYP3A4 inducer) on single dose PK of casdatifan in healthy adults.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
14
Administered as a single dose in treatment Periods 1, 2, and 3
Administered as multiple doses in treatment Period 2
Administered as multiple doses in treatment Period 3
Celerion
Tempe, Arizona, United States
Area Under the Plasma Drug Concentration-Time Curve (AUC) for casdatifan
Time frame: Up to 168 hours post dose for Period 1; up to 216 hours post dose for Period 2; and up to 120 hours post dose for Period 3
Maximum Concentration (Cmax) in Plasma for casdatifan
Time frame: Up to 168 hours post dose for Period 1; up to 216 hours post dose for Period 2; and up to 120 hours post dose for Period 3
Time to Maximum Concentration (Tmax) in Plasma for casdatifan
Time frame: Up to 168 hours post dose for Period 1; up to 216 hours post dose for Period 2; and up to 120 hours post dose for Period 3
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 26.2 weeks
Concentration observed at the end of the dosing interval (Ctrough) for itraconazole (Period 2) and phenytoin (Period 3)
Time frame: Up to 18 days
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