ClinicalTrials.Veeva

Menu

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

D

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)

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

Trial contacts and locations

1

Loading...

Central trial contact

Anhye Kim, Ph.D

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems