This study is an open-label, fixed-sequence, two-period Phase 1 clinical trial in healthy adult Chinese participants with a total of 3 cohorts, 16-20 healthy adult Chinese participants are planned to be enrolled in each cohort.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
60
Shandong University of Qilu Hospital
Jinan, Shandong, China
RECRUITINGMaximum observed concentration (Cmax) of SIM0270
To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants.
Time frame: Day 1-Day 13, Day 16-Day 30
Area under concentration curve from time 0 to the last quantifiable concentration (AUC0-t) of SIM0270
To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants.
Time frame: Day 1-Day 13, Day 16-Day 30
Area under concentration-time curve from time 0 to infinity (AUC0-∞) of SIM0270
To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants.
Time frame: Day 1-Day 13, Day 16-Day 30
Area under concentration-time curve from time 0 to tau (AUC0-tau) of SIM0270
To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants.
Time frame: Day 1-Day 13, Day 16-Day 30
Terminal half-life(t1/2)of SIM0270
To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants.
Time frame: Day 1-Day 13, Day 16-Day 30
Maximum observed concentration (Cmax) of SIM0270
To determine the effect of rifampicin on the PK of a single dose of SIM0270 in Chinese healthy adult participants.
Time frame: Day 1-Day 13, Day 20-Day 32
Area under concentration curve from time 0 to the last quantifiable concentration (AUC0-t) of SIM0270
To determine the effect of rifampicin on the PK of a single dose of SIM0270 in Chinese healthy adult participants.
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Time frame: Day 1-Day 13, Day 20-Day 32
Area under concentration-time curve from time 0 to infinity (AUC0-∞) of SIM0270
To determine the effect of rifampicin on the PK of a single dose of SIM0270 in Chinese healthy adult participants
Time frame: Day 1-Day 13, Day 20-Day 32
Terminal half-life(t1/2)of SIM0270
To determine the effect of rifampicin on the PK of a single dose of SIM0270 in Chinese healthy adult participants.
Time frame: Day 1-Day 13, Day 20-Day 32
Maximum observed concentration (Cmax) of midazolam
To determine the effect of SIM0270 on the PK of a single dose of midazolam in Chinese healthy adult male participants.
Time frame: Day 1-Day 2, Day 11-Day 13
Area under concentration curve from time 0 to the last quantifiable concentration (AUC0-t) of Midazolam
To determine the effect of SIM0270 on the PK of a single dose of midazolam in Chinese healthy adult male participants.
Time frame: Day 1-Day 2, Day 11-Day 13
Area under concentration-time curve from time 0 to infinity (AUC0-∞) of Midazolam
To determine the effect of SIM0270 on the PK of a single dose of midazolam in Chinese healthy adult male participants.
Time frame: Day 1-Day 2, Day 11-Day 13
Terminal half-life(t1/2)of midazolam
To determine the effect of SIM0270 on the PK of a single dose of midazolam in Chinese healthy adult male participants.
Time frame: Day 1-Day 2, Day 11-Day 13