Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction

NCT ID: NCT02754219

Last Updated: 2018-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-22

Study Completion Date

2018-01-19

Brief Summary

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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

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

Conditions

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Liver Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Evogliptin

Hepatic dysfunction, Healthy control

Group Type EXPERIMENTAL

Evogliptin

Intervention Type DRUG

DPP4-inhibitor, Evogliptin

Interventions

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Evogliptin

DPP4-inhibitor, Evogliptin

Intervention Type DRUG

Other Intervention Names

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DA-1229

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Hospital Clinical Trial Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DA1229_HI_I

Identifier Type: -

Identifier Source: org_study_id

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