Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05860582
Status:
COMPLETED
Last Update Posted:
2023-05-16
First Post:
2023-04-23
Brief Title:
A Study of 14CGB491 in Male Healthy Subjects
Sponsor:
Genor Biopharma Co Ltd
Organization:
Genor Biopharma Co Ltd
Study Overview
Official Title:
A Study of 14CGB491 on Mass Balance and Biotransformation in Chinese Male Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2023-05
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 an open-label single-center study to evaluate the mass-balance and pharmacokinetics of GB491 in 4-8 healthy male subjects receiving a single oral 150mg dose of GB491 containing approximately 50 uCi of 14CGB491 This study will help understand how the drug appears in the blood urine and feces after it is administered
In addition this study will also evaluate the safety of a single dose of 14CGB491 when given to healthy subjects
In addition this study will also evaluate the safety of a single dose of 14CGB491 when given to healthy subjects
Detailed Description:
None
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?:
None