Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction

D

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)

24 participants in 1 patient group

Evogliptin
Experimental group
Description:
Hepatic dysfunction, Healthy control
Treatment:
Drug: Evogliptin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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