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Completed

NCT Number: NCT05812417

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

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

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Key information

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHA Bundang Medical Center

Gyeonggi-do, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DA-8010

Drug

DA-8010 5mg single dose administration

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 13, 2023
Registry last updated
Jun 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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