Skip to main content
OpenTrials
Completed

NCT Number: NCT06485401

To Compare the Safety and PK/ PD Characteristics of ADC189 Between Hepatic Impairment and Normal Hepatic Function Subjects

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Soochow University

Suzhou, China

About this study

The evaluation of ADC189/ADC189-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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1) The subjects fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent, and can complete the entire trial process according to the requirements of the trial.
  • 2) Age 18-75 years old (including the boundary value), both male and female.
  • 3) The body weight of male subjects was ≥50 kg, the body weight of female subjects was ≥45 kg, and the body mass index (BMI) was within the range of 18.0~30.0 kg/m².

Exclusion criteria

  • 1) Known allergic history to test drug components, or allergic constitution, or history of allergic diseases.
  • 2) Have malignant tumors, or have a history of malignant tumors within 5 years prior to screening.
  • 3) Patients with severe infection, trauma, gastrointestinal surgery or other major surgical operations within 4 weeks before screening.
  • 4) eGFR (CKD-EPI Cr) <60mL/min/1.73m2.

Treatment and study plan

ADC189

Drug

45 mg per tablet, oral administration, single dose.

Primary outcomes

  1. Cmax of ADC189/ADC189-I07

    Time frame: 15 days

  2. AUClast of ADC189/ADC189-I07

    Time frame: 15 days

Sponsors and collaborators

Lead sponsor

Jiaxing AnDiCon Biotech Co.,Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 3, 2024
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.