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

Phase 1

Completed

• Conditions: Hemodialysis Patients
• Interventions: Drug: Evogliptin 5mg

• Registration Number: NCT04195919
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-12
• Study Start: 2020-07-10
• Primary Completion: 2021-05-24
• Study Completion: 2021-05-24
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-29
• Last Update Posted: 2021-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group2	Evogliptin 5mg	Healthy control(MDRD-eGFR ≥ 90 mL/min/1.73m2)
Group1	Evogliptin 5mg	Hemodialysis patients(MDRD-eGFR ≤ 15 mL/min/1.73m2)

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of