Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654791
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
Mass Balance Clinical Trial of SIM0270
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Clinical Study to Evaluate the Mass Balance of 14CSIM0270 in Healthy Chinese Adult Subjects
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-center non-randomized open-label single-cohort single-dose phase I clinical study in healthy Chinese adult male subjects
Detailed Description:
The main objectives of this study were as follows
1 To quantitatively analyze the total radioactivity in excreta of healthy subjects after a single oral administration of 14CSIM0270 and to obtain the data of human radioactive excretion rate and main excretion routes
2 After a single oral administration of 14CSIM0270 in healthy subjects radioactive metabolite profiles in plasma urine and feces were investigated to identify metabolites and the metabolic pathway main metabolites and elimination pathway of SIM0270 in human body were determined
3 The total radioactivity in whole blood and plasma of healthy subjects after a single oral administration of 14CSIM0270 was quantitatively analyzed the pharmacokinetic characteristics of total radioactivity in plasma were evaluated and the distribution of total radioactivity in whole blood and plasma was investigated
1 To quantitatively analyze the total radioactivity in excreta of healthy subjects after a single oral administration of 14CSIM0270 and to obtain the data of human radioactive excretion rate and main excretion routes
2 After a single oral administration of 14CSIM0270 in healthy subjects radioactive metabolite profiles in plasma urine and feces were investigated to identify metabolites and the metabolic pathway main metabolites and elimination pathway of SIM0270 in human body were determined
3 The total radioactivity in whole blood and plasma of healthy subjects after a single oral administration of 14CSIM0270 was quantitatively analyzed the pharmacokinetic characteristics of total radioactivity in plasma were evaluated and the distribution of total radioactivity in whole blood and plasma was investigated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None