RecruitingPhase 1NCT05747664

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

Sponsor

Daewoong Pharmaceutical Co. LTD.

Enrollment

24 participants

Start Date

Apr 13, 2023

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 2

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.

Eligibility

Min Age: 19 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing how a new diabetes drug (DWP16001, an SGLT2 inhibitor) behaves in the body of people with liver problems versus people with normal liver function. This helps researchers determine if dose adjustments are needed for patients with liver disease. **You may be eligible if...** - You are between 19 and 80 years old - Your body weight is between 45–90 kg and your BMI is 18–30 - You are either in the group with liver impairment or the healthy control group **You may NOT be eligible if...** - You have a history of significant gastrointestinal disease or surgery (except simple appendectomy) - You have a known allergy to SGLT2 inhibitor medications - You have significant kidney disease (creatinine >1.5 mg/dL or eGFR <60) - You have taken an SGLT2 inhibitor drug within the past 2 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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