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

Sponsor

Dong-A ST Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05812417

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Renal Impairment Healthy	Drug: DA-8010	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Normal renal function eGFR >=90 mL/min/1.73m^2	Drug: DA-8010 DA-8010 5mg single dose administration
Experimental: Mild renal impairment eGFR 60~89 mL/min/1.73m^2	Drug: DA-8010 DA-8010 5mg single dose administration
Experimental: Moderate renal impairment eGFR 30~59 mL/min/1.73m^2	Drug: DA-8010 DA-8010 5mg single dose administration
Experimental: Severe renal impairment eGFR 15~29 mL/min/1.73m^2	Drug: DA-8010 DA-8010 5mg single dose administration

Outcome Measures

Primary Outcome Measures

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHA Bundang Medical Center	Gyeonggi-do		Korea, Republic of

Sponsors and Collaborators

Dong-A ST Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dong-A ST Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05812417

Other Study ID Numbers:

DA8010_RI_I

First Posted:

Apr 13, 2023

Last Update Posted:

Apr 13, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Renal Insufficiency

DA-8010

Study Results

No Results Posted as of Apr 13, 2023