Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction

Dong-A ST Co., Ltd.24 enrolled

Overview

The objective of the study is to compare the pharmacokinetics profiles and safety of Evogliptin in patients wit hepatic dysfunction versus healthy volunteers after single oral dose of Evogliptin

When the future evogliptin be administered to liver dysfunction patients, to investgate whether dose adjustment is necessary.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Liver Dysfunction

Interventions

EvogliptinDRUG

DPP4-inhibitor, Evogliptin

Eligibility

Sex: ALLMin age: 19 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: \<Hepatic Dysfunction\> * At least 6 months with chronic liver disease (Regardless of cause hepatic dysfunction) * Child-Pugh A or B \<Healthy Control\> * Subject has the following conditions: age ± 5 years, BMI ± 20%, same sex of each matched hepatic dysfunction subject Exclusion Criteria: \<Hepatic Dysfunction\> * Child-Pugh C * History of Liver transplant \<Healthy Control\> * History of chronic liver disorders * Pregnant or lactating women

Locations (1)

Severance Hospital Clinical Trial Center

Seoul, South Korea

Outcomes

Primary Outcomes

Pharmacokinetic(Cmax of Evogliptin)

Time frame: Day1, Day2, Day3, Day4, Day5, Day6

Data from ClinicalTrials.gov

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