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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05747664

Enrollment

Registered

2023-02-28

Start date

2023-04-13

Completion date

2024-04-30

Last updated

2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

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.

Interventions

DRUGDWP16001

0.3mg

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Cmax of DWP16001	0 to 48 hours	Cmax of DWP16001
AUClast of DWP16001	0 to 48 hours	AUClast of DWP16001

Countries

South Korea

Contacts

Primary ContactYounghee Kim

2210285@daewoong.co.kr82-10-5768-9733

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026