This is a non-randomized, open-label, single-dose, Phase I clinical study to evaluate the mass balance and biotransformation, safety and tolerability of SIM0417 in healthy Chinese adult male subjects following a single oral administration of SIM0417 in combination with ritonavir.
This is a single-center, non-randomized, open-label, single-cohort, single-dose, Phase I clinical study to evaluate the mass balance, biotransformation, safety, and tolerability of SIM0417 following a single oral administration of SIM0417 combination with ritonavir in healthy Chinese adult male subjects. This study is planned to enroll 6-8 healthy male subjects, each subject will receive SIM0417 combined with ritonavir administration. SIM0417 is single dosed, and ritonavir is administered 12 hours before SIM0417 administration (-12h), at the time of SIM0417 administration (0h), 12h (12h), and 24h (24h) after SIM0417 administration. SIM0417 is administered after meals, ritonavir is administered either in fasting condition or after meals.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Single oral dose of 750 mg SIM0417 coadministered with 100 mg ritonavir.
Shandong First Medical University
Jinan, Shandong, China
Total recovery of SIM0417-related substances in urine
Total recovery of SIM0417-related substances in urine after a single dose of SIM0417 in combination with ritonavir, elucidating the main route of excretion, and clarifying the cumulative recovery of the parent drug and its metabolites (if applicable)
Time frame: Up to 168 hours(approx) from SIM0417 administration
Total recovery of SIM0417-related substances in feces
Total recovery of SIM0417-related substances in feces after a single dose of SIM0417 in combination with ritonavir, elucidating the main route of excretion, and clarifying the cumulative recovery of the parent drug and its metabolites (if applicable)
Time frame: Up to 168 hours(approx) from SIM0417 administration
Identification of metabolites in plasma
Identification of metabolites in plasma (if applicable), to identification of major biotransformation pathways
Time frame: Up to 72 hours (approx) from SIM0417 administration
Identification of metabolites in urine
Identification of metabolites in urine (if applicable), to identification of major biotransformation pathways
Time frame: Up to 168 hours (approx) from SIM0417 administration
Identification of metabolites in feces
Identification of metabolites in feces (if applicable), to identification of major biotransformation pathways
Time frame: Up to 168 hours (approx) from SIM0417 administration
Adverse Events
Number of Participants With Adverse Events
Time frame: Up to 14 days from SIM0417 administration
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Vital Signs
Number of Participants With Clinically Notable Vital Signs
Time frame: Up to 8 days from SIM0417 administration
ECG
Number of Participants With Clinically Notable Electrocardiogram (ECG) Values
Time frame: Up to 8 days from SIM0417 administration
Laboratory Tests
Number of Participants With Clinically Notable Laboratory Tests
Time frame: Up to 8 days from SIM0417 administration