Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-30 @ 5:23 AM
Study NCT ID:
NCT06852092
Status:
COMPLETED
Last Update Posted:
2025-02-28
First Post:
2025-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Mass Balance of [14C]HSK39297 in Healthy Chinese Adult Male Subjects
Sponsor:
Haisco Pharmaceutical Group Co., Ltd.
Organization:
Study Overview
Official Title:
Study on Mass Balance of [14C]HSK39297 in Healthy Chinese Adult Male Subjects
Status:
COMPLETED
Status Verified Date:
2025-02
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:
To evaluate the absorption, metabolism and excretion in healthy Chinese male subjects after a single oral dose of \[14C\]HSK39297
Detailed Description:
1. To quantitatively analyze the total radioactivity in excreta after oral administration of \[14C\]HHSK39297 in healthy subjects, obtain the data on human radioactivity excretion rate and determine the main excretion pathways
2. To quantitatively analyze the total radioactivity in whole blood and plasma in healthy subjects after oral administration of \[14C\]HSK39297, to obtain the pharmacokinetics of total radioactivity in plasma and to investigate the distribution of total radioactivity in whole blood and plasma
3. To obtain the radioactive metabolite profile in plasma, urine, and feces after oral administration of \[14C\]HSK39297 in healthy subjects, to identify the main metabolites and to determine the metabolism and elimination pathways
2. To quantitatively analyze the total radioactivity in whole blood and plasma in healthy subjects after oral administration of \[14C\]HSK39297, to obtain the pharmacokinetics of total radioactivity in plasma and to investigate the distribution of total radioactivity in whole blood and plasma
3. To obtain the radioactive metabolite profile in plasma, urine, and feces after oral administration of \[14C\]HSK39297 in healthy subjects, to identify the main metabolites and to determine the metabolism and elimination pathways
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?:
False
Is an FDA AA801 Violation?: