A Study to Evaluate the Effects of Renal Function on Pharmacokinetics and Safety of DA-8010
- Registration Number
- NCT05812417
- Lead Sponsor
- Dong-A ST Co., Ltd.
- Brief Summary
This Study will evaluate the effects of renal function on pharmacokinetics and safety of DA-8010
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mild renal impairment DA-8010 eGFR 60\~89 mL/min/1.73m\^2 Severe renal impairment DA-8010 eGFR 15\~29 mL/min/1.73m\^2 Moderate renal impairment DA-8010 eGFR 30\~59 mL/min/1.73m\^2 Normal renal function DA-8010 eGFR \>=90 mL/min/1.73m\^2
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CHA Bundang Medical Center
🇰🇷Gyeonggi-do, Korea, Republic of