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Completed

NCT Number: NCT02754219

Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction

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

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Key information

Conditions

Liver Dysfunction Diabetes Mellitus Diabetes Mellitus, Type 2 Digestive System Diseases Endocrine System Diseases Glucose Metabolism Disorders Liver Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Severance Hospital Clinical Trial Center

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evogliptin

Drug

DPP4-inhibitor, Evogliptin

Other names: DA-1229

Primary outcomes

  1. Pharmacokinetic(Cmax of Evogliptin)

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

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 28, 2016
Registry last updated
Feb 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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