Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584058
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
HPP737 Substance Balance Study in Human
Sponsor:
None
Organization:
None
Study Overview
Official Title:
14C A Single-center Nonrandomized Open Single-dose Substance Balance Study of HPP737 in Healthy Subjects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
Main research purpose
1 Quantitative analysis of the total amount of radioactivity in excreta urine and feces of male healthy subjects after oral administration of 14CHPP737 to obtain the cumulative excretion rate and main excretion routes of human radioactivity
2 To identify the main metabolites in the offspring of 14CHPP737 in healthy male subjects and to determine the main biotransformation pathway and main metabolite structure
3 To investigate the distribution of total radioactivity in whole blood and plasma and the pharmacokinetics of total plasma radioactivity in healthy male subjects after a single oral administration of 14CHPP737
Participants will
1 Take Investigational product once
2 Stay in the clinic about 7 days for checkups and tests
3 Report their symptoms
1 Quantitative analysis of the total amount of radioactivity in excreta urine and feces of male healthy subjects after oral administration of 14CHPP737 to obtain the cumulative excretion rate and main excretion routes of human radioactivity
2 To identify the main metabolites in the offspring of 14CHPP737 in healthy male subjects and to determine the main biotransformation pathway and main metabolite structure
3 To investigate the distribution of total radioactivity in whole blood and plasma and the pharmacokinetics of total plasma radioactivity in healthy male subjects after a single oral administration of 14CHPP737
Participants will
1 Take Investigational product once
2 Stay in the clinic about 7 days for checkups and tests
3 Report their symptoms
Detailed Description:
None
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