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NCT02754219 Clinical Trial

Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction

Liver Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02754219
Other study ID # DA1229_HI_I
Secondary ID
Status Completed
Phase Phase 1
First received April 27, 2016
Last updated February 23, 2018
Start date September 22, 2016
Est. completion date January 19, 2018

Study information
Verified date February 2018
Source Dong-A ST Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date January 19, 2018
Est. primary completion date January 19, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 64 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Evogliptin
DPP4-inhibitor, Evogliptin

Locations
Country Name City State
Korea, Republic of Severance Hospital Clinical Trial Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetic(Cmax of Evogliptin) Day1, Day2, Day3, Day4, Day5, Day6
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