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

NCT ID: NCT05812417

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-02
• Study Completion Date: 2024-06-07

Brief Summary

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

Conditions

Renal Impairment; Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Normal renal function

eGFR \>=90 mL/min/1.73m\^2

Group Type: ACTIVE_COMPARATOR

DA-8010

Intervention Type: DRUG

DA-8010 5mg single dose administration

Mild renal impairment

eGFR 60\~89 mL/min/1.73m\^2

Group Type: EXPERIMENTAL

DA-8010

Intervention Type: DRUG

DA-8010 5mg single dose administration

Moderate renal impairment

eGFR 30\~59 mL/min/1.73m\^2

Group Type: EXPERIMENTAL

DA-8010

Intervention Type: DRUG

DA-8010 5mg single dose administration

Severe renal impairment

eGFR 15\~29 mL/min/1.73m\^2

Group Type: EXPERIMENTAL

DA-8010

Intervention Type: DRUG

DA-8010 5mg single dose administration

Interventions

DA-8010

DA-8010 5mg single dose administration

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHA Bundang Medical Center

Gyeonggi-do, , South Korea

Countries

South Korea

Other Identifiers

DA8010_RI_I

Identifier Type: -

Identifier Source: org_study_id