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

Healthy Clinical Trial

Official title:

An Open-label, Single-dose, Parallel-group Study to Evaluate the Effects of Renal Function on Pharmacokinetics and Safety of DA-8010

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05812417
• Other study ID #: DA8010_RI_I
• Status: Recruiting
• Phase: Phase 1
• Start date: April 10, 2023
• Est. completion date: March 2024

Study information

• Verified date: May 2023
• Source: Dong-A ST Co., Ltd.
• Contact: Anhye Kim, Ph.D
• Phone: 82-31-780-4933
• Email: ahkim1[@]cha.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• DA-8010
DA-8010 5mg single dose administration

Locations

Country	Name	City	State
Korea, Republic of	CHA Bundang Medical Center	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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