NCT04195919CompletedPhase 1
A Clinical Study to Investigate the Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of Evogliptin in Hemodialysis Patients
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Dong-A ST Co., Ltd.
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Cmax
Study Overview
Brief Summary
A clinical study to investigate the pharmacokinetics/ pharmacodynamics and safety/tolerability of Evogliptin in hemodialysis patients
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
Group1
Experimental
Hemodialysis patients(MDRD-eGFR ≤ 15 mL/min/1.73m2)
Intervention: Evogliptin 5mg (Drug)
Group2
Experimental
Healthy control(MDRD-eGFR ≥ 90 mL/min/1.73m2)
Intervention: Evogliptin 5mg (Drug)
Outcomes
Primary Outcomes
Cmax
Time Frame: 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
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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