NCT05747664

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

An Open-label, Multi-center, Parallel, Single Oral Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of DWP16001 in Subjects With Hepatic Impairment Compared With Subjects With Normal Hepatic Function

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of DWP16001 in subjects with hepatic impairment compared with subjects with normal hepatic function.

Detailed description

The study design is An open-label, multi-center, parallel, single oral dose study.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	DWP16001	0.3mg

Timeline

• Start date: 2023-04-13
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2023-02-28
• Last updated: 2024-04-08

Locations

1 site across 1 country: South Korea