Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction

Dong-A ST

Status and phase: Completed; Phase 1

Conditions: Liver Dysfunction

Treatments: Drug: Evogliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02754219

DA1229_HI_I

Details and patient eligibility

About

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

Full description

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

Enrollment: 24 patients

Sex: All

Ages: 19 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Evogliptin

Experimental group

Description:

Hepatic dysfunction, Healthy control

Treatment:

Drug: Evogliptin