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

NCT ID: NCT04195919

Last Updated: 2021-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-10

Study Completion Date

2021-05-24

Brief Summary

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

Detailed Description

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Conditions

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Hemodialysis Patients

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Group1

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

Group Type EXPERIMENTAL

Evogliptin 5mg

Intervention Type DRUG

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

Group2

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

Group Type EXPERIMENTAL

Evogliptin 5mg

Intervention Type DRUG

Participants receive Single oral administration of Evogliptin 5mg on day1

Interventions

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Evogliptin 5mg

Participants receive Single oral administration of Evogliptin 5mg on day1

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Suganon Suganon

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DA1229_ESRD_I

Identifier Type: -

Identifier Source: org_study_id