A Study to Evaluate the Effects of Renal Function on Pharmacokinetics and Safety of DA-8010

Study Overview
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Brief Summary
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This Study will evaluate the effects of renal function on pharmacokinetics and safety of DA-8010

Official Title
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An Open-label, Single-dose, Parallel-group Study to Evaluate the Effects of Renal Function on Pharmacokinetics and Safety of DA-8010

Conditions
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Healthy, Renal Impairment

Intervention / Treatment
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* Drug: DA-8010


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: [Healthy Volunteer] Adult male or female, 19 years to 75 years eGFR ≥ 90 mL/min/1.73m^2 Body weight over 45.0 kg and body mass index in the range of 18.0 to 40.0 kg/m^2 The subjects signed and dated informed consent form after hearing a detailed explanation of the study, fully understanding and determined voluntarily to participate The subjects who are judged appropriate to participate this clinical trial according to the physical examination, laboratory examination and questionnaire [Renal Impairment Patient] Adult male of female, 19 years to 75 years eGFR < 90 mL/min/1.73m^2, not on dialysis Body weight over 45.0 kg and body mass index in the range of 18.0 to 40.0kg/m^2 The subjects signed and dated informed consent form after hearing a detailed explanation of the study, fully understanding and determined voluntarily to participate The subjects who are judged appropriate to participate this clinical trial according to the physical examination, laboratory examination and questionnaire Exclusion Criteria: The subjects with acute illness The subjects with a history of gastrointestinal disease or surgery that may affect the absorption of Investigational Product The subjects hypersensitive to any of the Investigational Product components or other drug components The subjects who have continuously consumed excessive smoking or alcohol within 6 months of screening, or who cannot stop smoking, caffeine, or alcohol intake during hospitalization The subjects who have history of drug abuse The subjects who are pregnant or lactating The subjects who do not agree to exclude the possibility of pregnancy using the contraception from the date of the first administration of the Investigational Product until the 4 weeks after the last administration

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal renal function<br>eGFR >=90 mL/min/1.73m^2 | Drug: DA-8010<br>* DA-8010 5mg single dose administration<br>|
| Experimental: Mild renal impairment<br>eGFR 60 89 mL/min/1.73m^2 | Drug: DA-8010<br>* DA-8010 5mg single dose administration<br>|
| Experimental: Moderate renal impairment<br>eGFR 30 59 mL/min/1.73m^2 | Drug: DA-8010<br>* DA-8010 5mg single dose administration<br>|
| Experimental: Severe renal impairment<br>eGFR 15 29 mL/min/1.73m^2 | Drug: DA-8010<br>* DA-8010 5mg single dose administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration (AUClast) of DA-8010 |  | Pre-dose, 1hour, 2hour, 3hour, 3.5hour, 4hour, 4.5hour, 5hour, 5.5hour, 6hour, 6.5hour, 7hour, 8hour, 12hour, 24hour, 48hour post-dosing on Day 1 | 
| Peak Plasma Concentration (Cmax) of DA-8010 |  | Pre-dose, 1hour, 2hour, 3hour, 3.5hour, 4hour, 4.5hour, 5hour, 5.5hour, 6hour, 6.5hour, 7hour, 8hour, 12hour, 24hour, 48hour post-dosing on Day 1 |