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

Daewoong Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: DWP16001

Study type: Interventional

Funder types: Industry

Identifiers

NCT05747664

DW_DWP16001110

Details and patient eligibility

About

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.

Full description

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

Enrollment: 24 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

DWP16001 to normal haptic function

Experimental group

Description:

Normal hepatic function

Treatment:

Drug: DWP16001

DWP16001 to Child-Pugh Class A

Experimental group

Description:

Child-Pugh Class A

Treatment:

Drug: DWP16001

DWP16001 to Child-Pugh Class B

Experimental group

Description:

Child-Pugh Class B

Treatment:

Drug: DWP16001