Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
Study NCT ID:
NCT05731804
Status:
UNKNOWN
Last Update Posted:
2023-03-08
First Post:
2023-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hepatic Impairment and Renal Impairment Study of SIM0417 Combined With Ritonavir
Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Multicenter, Non-randomized, Open-label, Parallel Controlled Phase I Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of SIM0417/Ritonavir After a Single Dose in Subjects With Renal or Hepatic Impairment
Status:
UNKNOWN
Status Verified Date:
2023-03
Last Known Status:
NOT_YET_RECRUITING
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 multicenter, nonrandomized, open-label, parallel controlled Phase I clinical study to evaluate the Pharmacokinetics, Safety and Tolerability of SIM0417 combined with ritonavir after a single dose in subjects with mild and moderate renal impairment, moderate hepatic impairment, normal renal function, and normal hepatic function. It is divided into Part A (subjects with mild/moderate renal impairment and subjects with normal renal function) and Part B (subjects with moderate hepatic impairment and subjects with normal hepatic function).
Detailed Description:
This is a multicenter, non-randomized, open-label, parallel controlled Phase I clinical study to evaluate the Pharmacokinetics, Safety and Tolerability of SIM0417 combined with ritonavir after a single dose in subjects with mild and moderate renal impairment, moderate hepatic impairment, normal renal function, and normal hepatic function.
Part A includes 4 cohorts, each of which plans to enroll 6-12 subjects, for a total of 24-48 subjects. Participants will be allocated into normal renal function or mild/moderate renal impairment groups based on their estimated glomerular filtration rate.
Part B includes 2 cohorts, each of which plans to enroll 6-12 subjects, for a total of 12-24 subjects. Participants will be allocated into normal hepatic function or moderate hepatic impairment groups based on their Child-Pugh score.
Each subject will receive SIM0417 combined with ritonavir administration. SIM0417 is single-dosed, and ritonavir is administered 12 hours before SIM0417 administration (-12 hours), at the time of SIM0417 administration (0 hour), 12 hours (12 hours) after SIM0417 administration, and 24 hours (24 hours) after SIM0417 administration.
Part A includes 4 cohorts, each of which plans to enroll 6-12 subjects, for a total of 24-48 subjects. Participants will be allocated into normal renal function or mild/moderate renal impairment groups based on their estimated glomerular filtration rate.
Part B includes 2 cohorts, each of which plans to enroll 6-12 subjects, for a total of 12-24 subjects. Participants will be allocated into normal hepatic function or moderate hepatic impairment groups based on their Child-Pugh score.
Each subject will receive SIM0417 combined with ritonavir administration. SIM0417 is single-dosed, and ritonavir is administered 12 hours before SIM0417 administration (-12 hours), at the time of SIM0417 administration (0 hour), 12 hours (12 hours) after SIM0417 administration, and 24 hours (24 hours) after SIM0417 administration.
Study Oversight
Has Oversight DMC:
False
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?: