Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-03-03 @ 4:03 PM
Study NCT ID:
NCT05109832
Status:
COMPLETED
Last Update Posted:
2025-09-16
First Post:
2021-10-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]IMP4297 to China Healthy Male Subjects
Sponsor:
Impact Therapeutics, Inc.
Organization:
Study Overview
Official Title:
A Clinical Trial of the Absorption, Metabolism, and Excretion of [14C]IMP4297 in Chinese Adult Male Healthy Volunteers - A Human Material Balance and Biotransformation Study of [14C]IMP4297
Status:
COMPLETED
Status Verified Date:
2025-09
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:
A Phase I, Open-label Study of Absorption-Distribution-Metabolism-Excretion (ADME) of \[14C\]IMP4297 Following a Single Oral Dose to China Healthy Male Subjects
Detailed Description:
Study design A Phase I, single-center, open-label, single arm study is designed to evaluate Absorption-Distribution-Metabolism-Excretion (ADME) of \[14C\]IMP4297 Following a Single Oral Dose to China Healthy Male Subjects.
6-8 subjects are planned to be enrolled (at least 6 subjects complete the study)
6-8 subjects are planned to be enrolled (at least 6 subjects complete the study)
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?: