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

Hemodialysis Patients Clinical Trial

Official title:

A Clinical Study to Investigate the Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of Evogliptin in Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04195919
• Other study ID #: DA1229_ESRD_I
• Status: Completed
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Hemodialysis Patients

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