Ignite Creation Date:
2024-07-17 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06485401
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-15
Brief Title:
To Compare the Safety and PK PD Characteristics of ADC189 Between Hepatic Impairment and Normal Hepatic Function Subjects
Sponsor:
Jiaxing AnDiCon Biotech CoLtd
Organization:
Jiaxing AnDiCon Biotech CoLtd
Study Overview
Official Title:
An Phase I Open-label Multi-center Parallel Single Oral Dose Study to Evaluate the Pharmacokinetics Pharmacodynamics Safety and Tolerability of ADC189 in Subjects With Hepatic Impairment Child-Pugh A and B Compared With Subjects With Normal Hepatic Function
Status:
RECRUITING
Status Verified Date:
2024-06
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 aims to evaluate the pharmacokinetics pharmacodynamics safety and tolerability of ADC189 in subjects with hepatic impairment compared with subjects with normal hepatic function
Detailed Description:
The evaluation of ADC189ADC189-I07 in mild hepatic insufficiency Child-Pugh A moderate hepatic insufficiency Child-Pugh B the pharmacokinetic characteristics in subjects compared with normal liver function subjects which matched by sex age and BMI in order to provide a scientific basis for a reasonable dosage in patients with liver dysfunction
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