NCT02214693

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

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

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 11, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Last Updated

August 27, 2015

Status Verified

August 1, 2015

Enrollment Period

8 months

First QC Date

August 11, 2014

Last Update Submit

August 25, 2015

Conditions

Renal Impairment

Keywords

patients

Outcome Measures

Primary Outcomes (1)

  • Area Under Curve(AUC) last

    Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120h post-dose

Study Arms (4)

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

DA-1229DRUG
Also known as: Evogliptin
Group 1(Severe decrease in GFR)Group 2(Moderate decrease in GFR)Group 3(Mild decrease in GFR)Group 4(Normal GFR)

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Center, Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

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

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2014

First Posted

August 12, 2014

Study Start

July 1, 2014

Primary Completion

March 1, 2015

Last Updated

August 27, 2015

Record last verified: 2015-08

Locations

KR(1)