Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-27 @ 10:01 AM
Study NCT ID:
NCT05159895
Status:
COMPLETED
Last Update Posted:
2022-05-25
First Post:
2021-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic and Mass Balance Study of Oral-Administrated [14C]-DZD9008 in Healthy Male Subjects
Sponsor:
Dizal Pharmaceuticals
Organization:
Study Overview
Official Title:
A Phase 1, Single-Center, Nonrandomized, Open-label Pharmacokinetic and Mass Balance Study of Oral-Administrated [14C]-DZD9008 in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2022-05
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 phase 1, open-label, ADME study with single oral administration of \[14C\]-DZD9008 in healthy subjects.
Detailed Description:
Phase 1 study to evaluate the excretion of DZD9008 radioactive dose, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of \[14C\]-DZD9008 in healthy male subjects. The purpose of this study is to investigate ADME properties of DZD9008 by analyzing blood, urine and feces samples collected during the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?: