Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction

February 23, 2018 updated by: Dong-A ST Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Evogliptin
Hepatic dysfunction, Healthy control
Drug: Evogliptin
DPP4-inhibitor, Evogliptin
Other Names:
  • DA-1229

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic(Cmax of Evogliptin)
Time Frame: Day1, Day2, Day3, Day4, Day5, Day6
Day1, Day2, Day3, Day4, Day5, Day6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2016

Primary Completion (Actual)

January 19, 2018

Study Completion (Actual)

January 19, 2018

Study Registration Dates

First Submitted

April 27, 2016

First Submitted That Met QC Criteria

April 27, 2016

First Posted (Estimate)

April 28, 2016

Study Record Updates

Last Update Posted (Actual)

February 26, 2018

Last Update Submitted That Met QC Criteria

February 23, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA1229_HI_I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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