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

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

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: DWP16001


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. A person who is 19 years of age or more and under 80 years of age at the time of screening. 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: 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. 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. Serum Cr >1.5mg/dL or eGFR (CKD-EPI Cr) <60mL/min/1.73m2 Those who have used SGLT2 inhibitor family drugs within two weeks of the scheduled date of administration of DWP16001.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWP16001 to normal haptic function<br>Normal hepatic function | Drug: DWP16001<br>* 0.3mg<br>* Other names: DWP16001 0.3mg;|
| Experimental: DWP16001 to Child-Pugh Class A<br>Child-Pugh Class A | Drug: DWP16001<br>* 0.3mg<br>* Other names: DWP16001 0.3mg;|
| Experimental: DWP16001 to Child-Pugh Class B<br>Child-Pugh Class B | Drug: DWP16001<br>* 0.3mg<br>* Other names: DWP16001 0.3mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of DWP16001 | Cmax of DWP16001 | 0 to 48 hours | 
| AUClast of DWP16001 | AUClast of DWP16001 | 0 to 48 hours |