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

Primary Purpose

Renal Impairment, Healthy

Status
Recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DA-8010
Sponsored by
Dong-A ST Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Renal Impairment

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • CHA Bundang Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Normal renal function

Mild renal impairment

Moderate renal impairment

Severe renal impairment

Arm Description

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

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

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

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

Outcomes

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
Peak Plasma Concentration (Cmax) of DA-8010

Secondary Outcome Measures

Full Information

First Posted
March 20, 2023
Last Updated
May 10, 2023
Sponsor
Dong-A ST Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05812417
Brief Title
A Study to Evaluate the Effects of Renal Function on Pharmacokinetics and Safety of DA-8010
Official Title
An Open-label, Single-dose, Parallel-group Study to Evaluate the Effects of Renal Function on Pharmacokinetics and Safety of DA-8010
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment, Healthy

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Normal renal function
Arm Type
Active Comparator
Arm Description
eGFR >=90 mL/min/1.73m^2
Arm Title
Mild renal impairment
Arm Type
Experimental
Arm Description
eGFR 60~89 mL/min/1.73m^2
Arm Title
Moderate renal impairment
Arm Type
Experimental
Arm Description
eGFR 30~59 mL/min/1.73m^2
Arm Title
Severe renal impairment
Arm Type
Experimental
Arm Description
eGFR 15~29 mL/min/1.73m^2
Intervention Type
Drug
Intervention Name(s)
DA-8010
Intervention Description
DA-8010 5mg single dose administration
Primary Outcome Measure Information:
Title
Area under the plasma concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration (AUClast) of DA-8010
Time Frame
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
Title
Peak Plasma Concentration (Cmax) of DA-8010
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anhye Kim, Ph.D
Phone
82-31-780-4933
Email
ahkim1@cha.ac.kr
Facility Information:
Facility Name
CHA Bundang Medical Center
City
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anhye Kim, Ph.D

12. IPD Sharing Statement

Plan to Share IPD
Yes

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

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