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