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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04195919
Other study ID # DA1229_ESRD_I
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 10, 2020
Est. completion date May 24, 2021

Study information

Verified date November 2021
Source Dong-A ST Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date May 24, 2021
Est. primary completion date May 24, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Evogliptin 5mg
Participants receive Single oral administration of Evogliptin 5mg on day1
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

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary AUClast Area Under the plasma Concentration versus time curve(AUClast) of Evogliptin 1day(15day) pre-dose (0), 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48 hour post-dose
Primary Cmax Peak Plasma Concentration(Cmax) of Evogliptin 1day(15day) pre-dose (0), 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48 hour post-dose
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