Overview

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

Status:
Not yet recruiting
Trial end date:
2024-03-01
Target enrollment:
0
Participant gender:
All
Summary
This Study will evaluate the effects of renal function on pharmacokinetics and safety of DA-8010
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Dong-A ST Co., Ltd.
Treatments:
DA-8010
Criteria
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