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NOT YET RECRUITING
NCT07877038
PHASE1

Pharmacokinetics, Safety, and Tolerability of DA-302168S Tablets in Participants With Hepatic Impairment and Normal Hepatic Function

Sponsor: Chendu DIAO Pharmaceutical Group CO., LTD.

View on ClinicalTrials.gov

Summary

This is an open-label, non-randomized study to assess how DA-302168S is absorbed, distributed, metabolized, and eliminated after a single oral dose. The study includes three groups: subjects with mild hepatic impairment (Child-Pugh Class A), subjects with moderate hepatic impairment (Child-Pugh Class B), and healthy subjects matched by gender, age, and body mass index (BMI). It will also explore the relationship between baseline liver function measures and the pharmacokinetic (PK) parameters of DA-302168S, to support appropriate dosing recommendations for patients with liver impairment.

Official title: A Study to Evaluate the Pharmacokinetic Characteristics, Safety, and Tolerability of DA-302168S Tablets in Trial Participants With Varying Degrees of Hepatic Impairment and in Those With Normal Hepatic Function

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2026-10-22

Completion Date

2027-04-07

Last Updated

2026-10-15

Healthy Volunteers

Yes

Interventions

DRUG

DA-302168S

Small molecule GLP-1RA tablet