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The Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of Evogliptin in Hemodialysis Patients

Sponsor
Dong-A ST Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT04195919
Collaborator
(none)
17
Enrollment
1
Location
2
Arms
10.4
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A clinical study to investigate the pharmacokinetics/ pharmacodynamics and safety/tolerability of Evogliptin in hemodialysis patients

Condition or Disease Intervention/Treatment Phase
  • Drug: Evogliptin 5mg
  • Drug: Evogliptin 5mg
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
A Clinical Study to Investigate the Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of Evogliptin in Hemodialysis Patients
Actual Study Start Date :
Jul 10, 2020
Actual Primary Completion Date :
May 24, 2021
Actual Study Completion Date :
May 24, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group1

Hemodialysis patients(MDRD-eGFR ≤ 15 mL/min/1.73m2)

Drug: Evogliptin 5mg
Period 1(1d,After hemodialysis) → Wash-out period → Period 2(15d,Before hemodialysis) Hemodialysis patients receive Single oral administration of Evogliptin 5mg on day1 and day15 With a 14-day washout period
Other Names:
  • Suganon

    		•
    Experimental: Group2

    Healthy control(MDRD-eGFR ≥ 90 mL/min/1.73m2)

    Drug: Evogliptin 5mg
    Participants receive Single oral administration of Evogliptin 5mg on day1
    Other Names:
  • Suganon

    		•

    Outcome Measures

    Primary Outcome Measures

    1. AUClast [1day(15day) pre-dose (0), 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48 hour post-dose]

      Area Under the plasma Concentration versus time curve(AUClast) of Evogliptin

    2. Cmax [1day(15day) pre-dose (0), 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48 hour post-dose]

      Peak Plasma Concentration(Cmax) of Evogliptin

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Subjects who aged 20 to 80 at the time of screening

    2. Subjects with 50.0kg≤Body Weight≤90.0kg and 18.0kg/m2≤BMI≤27.0kg/m2

    3. Subjects who meet the following kidney functions

    • group1(hemodialysis patients): MDRD-eGFR ≤ 15 mL/min/1.73m2

    • group2(helthy control): MDRD-eGFR ≥ 90 mL/min/1.73m2

    Exclusion Criteria:

    1. Subjects who have a uncontrolled or unstable disease such as liver, nervous system, immune system, respiratory system, endocrine system or blood / tumor disease, cardiovascular disease, mental disorders (mood disorder, obsessive compulsive disorder, etc.) or history

    2. Subjects who have a gastrointestinal disease (such as Crohn's disease, ulcers, acute or chronic pancreatitis, etc.) or history of gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect the absorption of the test drug.

    3. Subjects with a history of significant hypersensitivity reaction such as anaphylaxis or angioedema to DPP-IV inhibitors

    4. Subjects who have AST (SGOT) and ALT (SGPT) greater than 1.5 times the upper limit of normal range, at the time of screening test including additional tests.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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:
    NCT04195919
    Other Study ID Numbers:
    • DA1229_ESRD_I
    First Posted:
    Dec 12, 2019
    Last Update Posted:
    Dec 1, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Dec 1, 2021