Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438367
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-27
Brief Title:
TGRX-326 Pharmacokinetic Mass Balance
Sponsor:
Shenzhen TargetRx Inc
Organization:
Shenzhen TargetRx Inc
Study Overview
Official Title:
Mass Balance Study of 14CTGRX-326 in Healthy Adult Chinese Male Participants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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 a pharmacokinetic study for TGRX-326 on mass balance to evaluate distribution metabolism and excretion of TGRX-326 an ALK inhibitor indicated for treatment of Non-small cell lung cancer
Detailed Description:
This study is designed as a single-center single-dose non-randomized and open-label study The study will be conducted in healthy male participants to evaluate distribution metabolic pathways and route of excretion of TGRX-326 using the Carbon-14 labelled isotope of TGRX-326 compound Safety evaluation will also be conducted
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