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

NCT05812417 | Completed Phase 1

• 1 other identifier: DA8010_RI_I
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Renal Impairment; Healthy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Normal renal function

ACTIVE COMPARATOR

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

Drug: DA-8010

Mild renal impairment

EXPERIMENTAL

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

Drug: DA-8010

Moderate renal impairment

EXPERIMENTAL

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

Drug: DA-8010

Severe renal impairment

EXPERIMENTAL

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

Drug: DA-8010

Interventions

DA-8010 DRUG

DA-8010 5mg single dose administration

Mild renal impairment; Moderate renal impairment; Normal renal function; Severe renal impairment

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \[Healthy Volunteer\]
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

CHA Bundang Medical Center

Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

DA-8010

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 13, 2023
• Study Start: May 2, 2023
• Primary Completion: June 7, 2024
• Study Completion: June 7, 2024
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)