Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-26 @ 1:05 AM
Study NCT ID:
NCT05475834
Status:
COMPLETED
Last Update Posted:
2022-10-03
First Post:
2022-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Investigate the Mass Balance and Biotransformation of SIM0417 in Healthy Adult Chinese Male Participants
Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase I Study to Investigate The Mass Balance and Biotransformation of SIM0417 in Healthy Adult Chinese Male Participants
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: