NCT02754219

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

September 22, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2018

Completed
Last Updated

February 26, 2018

Status Verified

February 1, 2018

Enrollment Period

1.3 years

First QC Date

April 27, 2016

Last Update Submit

February 23, 2018

Conditions

Liver Dysfunction

Keywords

Diabetes Mellitus, Type II

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic(Cmax of Evogliptin)

    Day1, Day2, Day3, Day4, Day5, Day6

Study Arms (1)

Evogliptin

EXPERIMENTAL

Hepatic dysfunction, Healthy control

Drug: Evogliptin

Interventions

EvogliptinDRUG

DPP4-inhibitor, Evogliptin

Also known as: DA-1229
Evogliptin

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \<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

You may not qualify if:

  • \<Hepatic Dysfunction\>
  • Child-Pugh C
  • History of Liver transplant
  • \<Healthy Control\>
  • History of chronic liver disorders
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital Clinical Trial Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Liver DiseasesDiabetes Mellitus, Type 2

Interventions

4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one

Condition Hierarchy (Ancestors)

Digestive System DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2016

First Posted

April 28, 2016

Study Start

September 22, 2016

Primary Completion

January 19, 2018

Study Completion

January 19, 2018

Last Updated

February 26, 2018

Record last verified: 2018-02

Locations

KR(1)