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

Phase 1

Recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: DWP16001

• Registration Number: NCT05747664
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief 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.

Study Timeline

• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-17
• Study First Posted: 2023-02-28
• Study Start: 2023-04-13
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-05
• Last Update Posted: 2024-04-08
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. A person who has decided to participate voluntarily and agreed in writing prior to the screening procedure after understanding the detailed explanation of this clinical trial.
2. A person who is 19 years of age or more and under 80 years of age at the time of screening.
3. Those with a weight of 45.0 kg or more and 90.0 kg or less and a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less.

Exclusion Criteria

1. A person who has a history of gastrointestinal diseases (e.g., ulcer, inflammatory bowel disease, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect the absorption of DWP16001.
2. Those who are hypersensitive to drugs and other drugs (aspirin, antibiotics, etc.) including the SGLT2 inhibitor family or who have a history of clinically significant hypersensitivity reaction.
3. Serum Cr >1.5mg/dL or eGFR (CKD-EPI Cr) <60mL/min/1.73m2
4. Those who have used SGLT2 inhibitor family drugs within two weeks of the scheduled date of administration of DWP16001.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DWP16001 to Child-Pugh Class B	DWP16001	Child-Pugh Class B
DWP16001 to Child-Pugh Class A	DWP16001	Child-Pugh Class A
DWP16001 to normal haptic function	DWP16001	Normal hepatic function

Primary Outcome Measures

Name	Time	Method
AUClast of DWP16001	0 to 48 hours	AUClast of DWP16001
Cmax of DWP16001	0 to 48 hours	Cmax of DWP16001

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of