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

Sponsor
Dong-A ST Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02214693
Collaborator
(none)
30
Enrollment
1
Location
4
Arms

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Official Title:
A Clinical Study to Investigate the Pharmacokinetics/Pharmacodynamics and Tolerability of DA-1229(Evogliptin) Tablet in Renal Impaired Patients
Study Start Date :
Jul 1, 2014
Actual Primary Completion Date :
Mar 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Trial Center, Seoul National University Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Dong-A ST Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dong-A ST Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT02214693
    Other Study ID Numbers:
    • DA1229_RI_I
    First Posted:
    Aug 12, 2014
    Last Update Posted:
    Aug 27, 2015
    Last Verified:
    Aug 1, 2015
    Keywords provided by Dong-A ST Co., Ltd.
    patients
    Additional relevant MeSH terms:
    Renal Insufficiency

    Study Results

    No Results Posted as of Aug 27, 2015