This drug-drug interaction (DDI) study has been designed to characterize the pharmacokinetic profile of SHR8554 when co administered with a strong cytochrome P450 3A4 (CYP3A4) inhibitor itraconazole
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Drug: SHR8554 Administered as specified in the treatment arm Drug: Itraconazole Administered as specified in the treatment arm
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, China
Cmax:observed maximum plasma concentration
Time frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
AUC0-t :area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration
Time frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
AUC0-∞:area under the plasma concentration-time curve from time 0 to infinity
Time frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
Tmax:observed time to reach Cmax
Time frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
Vz :apparent volume of distribution
Time frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
MRT0-∞:mean residence time from time 0 to infinity
Time frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Baseline up to Day 18
Incidence of participants with clinical laboratory abnormalities
Time frame: Baseline up to Day 18
Incidence of participants with vital signs abnormalities
Time frame: Baseline up to Day 18
Incidence of participants with physical exam abnormalities
Time frame: Baseline up to Day 18
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