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

Dong-A ST

Status and phase: Completed; Phase 1

Conditions: Hemodialysis Patients

Treatments: Drug: Evogliptin 5mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04195919

DA1229_ESRD_I

Details and patient eligibility

About

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

Enrollment: 17 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

17 participants in 2 patient groups

Group1

Experimental group

Description:

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

Treatment:

Drug: Evogliptin 5mg

Drug: Evogliptin 5mg

Group2

Experimental group

Description:

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

Treatment:

Drug: Evogliptin 5mg

Drug: Evogliptin 5mg