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

NCT04195919 | Completed Phase 1

• 1 other identifier: DA1229_ESRD_I
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemodialysis Patients

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Group1

EXPERIMENTAL

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

Drug: Evogliptin 5mg

Group2

EXPERIMENTAL

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

Drug: Evogliptin 5mg

Interventions

Evogliptin 5mg DRUG

Participants receive Single oral administration of Evogliptin 5mg on day1

Also known as: Suganon

Group2

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who aged 20 to 80 at the time of screening
• Subjects with 50.0kg≤Body Weight≤90.0kg and 18.0kg/m2≤BMI≤27.0kg/m2
• 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

You may not qualify if:

• 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
• 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.
• Subjects with a history of significant hypersensitivity reaction such as anaphylaxis or angioedema to DPP-IV inhibitors
• 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.

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 12, 2019
• Study Start: July 10, 2020
• Primary Completion: May 24, 2021
• Study Completion: May 24, 2021
• Last Updated: December 1, 2021

Record last verified: 2021-11

Locations

KR (1)