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

August 25, 2015 updated by: Dong-A ST Co., Ltd.

A Clinical Study to Investigate the Pharmacokinetics/Pharmacodynamics and Tolerability of DA-1229(Evogliptin) Tablet in Renal Impaired Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Clinical Trial Center, Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1(Severe decrease in GFR)
Severe decrease in GFR
Drug: DA-1229
Other Names:
  • Evogliptin
Experimental: Group 2(Moderate decrease in GFR)
Moderate decrease in GFR
Drug: DA-1229
Other Names:
  • Evogliptin
Experimental: Group 3(Mild decrease in GFR)
Mild decrease in GFR
Drug: DA-1229
Other Names:
  • Evogliptin
Experimental: Group 4(Normal GFR)
Normal GFR
Drug: DA-1229
Other Names:
  • Evogliptin

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

August 11, 2014

First Submitted That Met QC Criteria

August 11, 2014

First Posted (Estimate)

August 12, 2014

Study Record Updates

Last Update Posted (Estimate)

August 27, 2015

Last Update Submitted That Met QC Criteria

August 25, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA1229_RI_I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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