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

Dong-A ST

Status and phase: Completed; Phase 1

Conditions: Healthy; Renal Impairment

Treatments: Drug: DA-8010

Study type: Interventional

Funder types: Industry

Identifiers

NCT05812417

DA8010_RI_I

Details and patient eligibility

About

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

Enrollment: 33 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 4 patient groups

Normal renal function

Active Comparator group

Description:

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

Treatment:

Drug: DA-8010

Mild renal impairment

Experimental group

Description:

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

Treatment:

Drug: DA-8010

Moderate renal impairment

Experimental group

Description:

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

Treatment:

Drug: DA-8010

Severe renal impairment

Experimental group

Description:

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

Treatment:

Drug: DA-8010