Pharmacokinetics and Safety of Evogliptin in Subjects Wit... | NCT02754219

Studies
Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction

NCT02754219

Sponsor

Dong-A ST Co., Ltd.

Status

Completed

Last Update Posted

Feb 26, 2018Actual

Enrollment

24Actual

Phase

Phase 1

Conditions

Liver Dysfunction

Interventions

Evogliptin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 22, 2016Actual

Primary Completion Date

Jan 19, 2018Actual

Completion Date

Jan 19, 2018Actual

First Submitted Date

Apr 27, 2016

First Submission Date that Met QC Criteria

Apr 27, 2016

First Posted Date

Apr 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2018

Last Update Posted Date

Feb 26, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Evogliptin	Experimental	Hepatic dysfunction, Healthy control	Drug: Evogliptin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Evogliptin	Drug	DPP4-inhibitor, Evogliptin	Evogliptin	DA-1229

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetic(Cmax of Evogliptin)		Day1, Day2, Day3, Day4, Day5, Day6

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At least 6 months with chronic liver disease (Regardless of cause hepatic dysfunction)
Child-Pugh A or B

Subject has the following conditions: age ± 5 years, BMI ± 20%, same sex of each matched hepatic dysfunction subject

Exclusion Criteria:

Child-Pugh C
History of Liver transplant

History of chronic liver disorders
Pregnant or lactating women

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Severance Hospital Clinical Trial Center		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008107	Liver Diseases
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D004066	Digestive System Diseases
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C557982	4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided