Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction

A Study to Evaluate Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction and Control Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02754219

Enrollment

Registered

2016-04-28

Start date

2016-09-22

Completion date

2018-01-19

Last updated

2018-02-26

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

Conditions

Liver Dysfunction

Keywords

Diabetes Mellitus, Type II

Brief summary

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

Detailed description

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

Interventions

DRUGEvogliptin

DPP4-inhibitor, Evogliptin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 64 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic(Cmax of Evogliptin)	Day1, Day2, Day3, Day4, Day5, Day6

Countries

South Korea

Outcome results

None listed

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