Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360796
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-04-03
Brief Title:
Study of Pharmacokinetics and Metabolism on 14CADC189
Sponsor:
Jiaxing AnDiCon Biotech CoLtd
Organization:
Jiaxing AnDiCon Biotech CoLtd
Study Overview
Official Title:
A Phase I Study to Investigate the Absorption Metabolism Excretion and Safety of 14CADC189 in Healthy Chinese Male Volunteers
Status:
RECRUITING
Status Verified Date:
2024-03
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 study is designed to determined the metabolism excretion and substance balance of almonertinib of ADC189 The pharmacokinetic characteristics and safety profile of ADC189 was investigated following a single oral dose 45 mg100 µCi in healthy Chinese male participants
Detailed Description:
This study adopted a single-center open non-randomized single-dose design Six to eight healthy Chinese male subjects were planned to be enrolled and the final aim is to collect all required samples and data from at least 6 subjects
After each subject take a single oral dose of 45 mg about 100 μCi 14CADC189 on Day 1 whole blood plasma urine and feces samples were collected at specified time points during the study The total radioactivity was measured to calculate the ratio of total radioactivity of whole blood to total radioactivity of plasma pharmacokinetic parameters recovery rate and excretion pathway data of total radioactivity in whole blood and plasma Meanwhile the radioactive metabolite spectrum and structural identification of main metabolites in plasma urine and feces were performed to obtain the pathway and characteristics of main metabolic elimination of ADC189 in human body as well as circulating metabolites 10 of total radioactivity exposure in plasma
After each subject take a single oral dose of 45 mg about 100 μCi 14CADC189 on Day 1 whole blood plasma urine and feces samples were collected at specified time points during the study The total radioactivity was measured to calculate the ratio of total radioactivity of whole blood to total radioactivity of plasma pharmacokinetic parameters recovery rate and excretion pathway data of total radioactivity in whole blood and plasma Meanwhile the radioactive metabolite spectrum and structural identification of main metabolites in plasma urine and feces were performed to obtain the pathway and characteristics of main metabolic elimination of ADC189 in human body as well as circulating metabolites 10 of total radioactivity exposure in plasma
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