Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction

Phase 1

Completed

• Conditions: Liver Dysfunction
• Interventions: Drug: Evogliptin

• Registration Number: NCT02754219
• Lead Sponsor: Dong-A ST Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2016-04-27
• Study First Submitted QC: 2016-04-27
• Study First Posted: 2016-04-28
• Study Start: 2016-09-22
• Primary Completion: 2018-01-19
• Study Completion: 2018-01-19
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-23
• Last Update Posted: 2018-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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Exclusion Criteria

<Hepatic Dysfunction>

• Child-Pugh C
• History of Liver transplant

<Healthy Control>

• History of chronic liver disorders
• Pregnant or lactating women

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Evogliptin	Evogliptin	Hepatic dysfunction, Healthy control

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic(Cmax of Evogliptin)	Day1, Day2, Day3, Day4, Day5, Day6

Trial Locations

Locations (1)

Severance Hospital Clinical Trial Center; 🇰🇷 Seoul, Korea, Republic of