Clinical trial NCT05812417: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Healthy
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-13
Enrollment: 33
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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


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

Primary outcomes:
measure: Area under the plasma concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration (AUClast) of DA-8010
timeFrame: 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
measure: Peak Plasma Concentration (Cmax) of DA-8010
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: CHA Bundang Medical Center
Study officials:
References: