PK//PD/Tolerability Study of DA-1229(Evogliptin) in Renal... | NCT02214693

Studies
PK//PD/Tolerability Study of DA-1229(Evogliptin) in Renal Impaired Patients

NCT02214693

Sponsor

Dong-A ST Co., Ltd.

Status

Completed

Last Update Posted

Aug 27, 2015Estimated

Enrollment

30Actual

Phase

Phase 1

Conditions

Renal Impairment

Interventions

DA-1229

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

Aug 2015

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

Jul 2014

Primary Completion Date

Mar 2015Actual

Completion Date

Not provided

First Submitted Date

Aug 11, 2014

First Submission Date that Met QC Criteria

Aug 11, 2014

First Posted Date

Aug 12, 2014Estimated

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

Aug 25, 2015

Last Update Posted Date

Aug 27, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This is a clinical study to investigate the pharmacokinetics/pharmacodynamics and tolerability of DA-1229(Evogliptin) tabletin renal impaired patients.

Detailed Description

Not provided

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1(Severe decrease in GFR)	Experimental	Severe decrease in GFR	Drug: DA-1229
Group 2(Moderate decrease in GFR)	Experimental	Moderate decrease in GFR	Drug: DA-1229
Group 3(Mild decrease in GFR)	Experimental	Mild decrease in GFR	Drug: DA-1229
Group 4(Normal GFR)	Experimental	Normal GFR	Drug: DA-1229

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DA-1229	Drug		Group 1(Severe decrease in GFR) Group 2(Moderate decrease in GFR) Group 3(Mild decrease in GFR) Group 4(Normal GFR)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area Under Curve(AUC) last		Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120h post-dose

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 20 and 70
Weights between 50 and 90kg(Female : 40 and 90kg)
Volunteer who totally understands the progress of this clinical trials, makes decision by his free will, and signed a consent form to follow the progress
Stable results of estimated GFR in 4 months recently

Exclusion Criteria:

Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder)
Volunteer who had drug(DPP-4 inhibitor) hypersensitivity reaction
Volunteer who already participated in other trials in 2 months
Volunteer who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder 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
Clinical Trial Center, Seoul National University Hospital		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D051437	Renal Insufficiency

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

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