NCT02754219CompletedPhase 1
A Study to Evaluate Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction and Control Healthy Volunteers
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Dong-A ST Co., Ltd.
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Pharmacokinetic(Cmax of Evogliptin)
Study Overview
Brief Summary
The objective of the study is to compare the pharmacokinetics profiles and safety of Evogliptin in patients wit hepatic dysfunction versus healthy volunteers after single oral dose of Evogliptin
Detailed Description
When the future evogliptin be administered to liver dysfunction patients, to investgate whether dose adjustment is necessary.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •<Hepatic Dysfunction>
- •At least 6 months with chronic liver disease (Regardless of cause hepatic dysfunction)
- •Child-Pugh A or B
- •<Healthy Control>
- •Subject has the following conditions: age ± 5 years, BMI ± 20%, same sex of each matched hepatic dysfunction subject
Exclusion Criteria
- •<Hepatic Dysfunction>
- •Child-Pugh C
- •History of Liver transplant
- •<Healthy Control>
- •History of chronic liver disorders
- •Pregnant or lactating women
Arms & Interventions
Evogliptin
Experimental
Hepatic dysfunction, Healthy control
Intervention: Evogliptin (Drug)
Outcomes
Primary Outcomes
Pharmacokinetic(Cmax of Evogliptin)
Time Frame: Day1, Day2, Day3, Day4, Day5, Day6
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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