Back to resultsPharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction
Primary Purpose
Liver Dysfunction
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Evogliptin
Sponsored by
About this trial
This is an interventional treatment trial for Liver Dysfunction focused on measuring Diabetes Mellitus, Type II
Eligibility Criteria
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
Sites / Locations
- Severance Hospital Clinical Trial Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Evogliptin
Arm Description
Hepatic dysfunction, Healthy control
Outcomes
Primary Outcome Measures
Pharmacokinetic(Cmax of Evogliptin)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02754219
Brief Title
Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction
Official Title
A Study to Evaluate Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction and Control Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
September 22, 2016 (Actual)
Primary Completion Date
January 19, 2018 (Actual)
Study Completion Date
January 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
When the future evogliptin be administered to liver dysfunction patients, to investgate whether dose adjustment is necessary.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Dysfunction
Keywords
Diabetes Mellitus, Type II
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Evogliptin
Arm Type
Experimental
Arm Description
Hepatic dysfunction, Healthy control
Intervention Type
Drug
Intervention Name(s)
Evogliptin
Other Intervention Name(s)
DA-1229
Intervention Description
DPP4-inhibitor, Evogliptin
Primary Outcome Measure Information:
Title
Pharmacokinetic(Cmax of Evogliptin)
Time Frame
Day1, Day2, Day3, Day4, Day5, Day6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Severance Hospital Clinical Trial Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction
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