Renal ImpairmentPhase 1NCT05812417
A Study to Evaluate the Effects of Renal Function on Pharmacokinetics and Safety of DA-8010
A Phase 1 study testing DA-8010 in people with Renal Impairment and Healthy, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
This Study will evaluate the effects of renal function on pharmacokinetics and safety of DA-8010 Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment, Healthy
- What is being tested?
- DA-8010
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 May 2023to 7 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- [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
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- [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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-dose, Parallel-group 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
- Conditions
- Renal Impairment, Healthy
- Being tested
- DA-8010
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-8010Drug
DA-8010 5mg single dose administration
| Study group | Role | What they receive |
|---|---|---|
| Normal renal function | Active comparator | eGFR >=90 mL/min/1.73m^2 Receives: Drug: DA-8010 |
| Mild renal impairment | Experimental | eGFR 60~89 mL/min/1.73m^2 Receives: Drug: DA-8010 |
| Moderate renal impairment | Experimental | eGFR 30~59 mL/min/1.73m^2 Receives: Drug: DA-8010 |
| Severe renal impairment | Experimental | eGFR 15~29 mL/min/1.73m^2 Receives: Drug: DA-8010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration (AUClast) of DA-8010
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start2 May 2023
- Primary completion7 Jun 2024
- Study completion7 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812417
- Sponsor's protocol ID
- DA8010_RI_I
- Status last verified
- Jun 2024
- First submitted
- 20 Mar 2023
- Last updated
- 26 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-dose, Parallel-group Study to Evaluate the Effects of Renal Function on Pharmacokinetics and Safety of DA-8010
- ClinicalTrials.gov ID
- NCT05812417
- Acronym / sponsor ID
- DA8010_RI_I
- Conditions
- Renal Impairment, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 May 2023 (actual)
- Primary completion
- 7 Jun 2024 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Study will evaluate the effects of renal function on pharmacokinetics and safety of DA-8010
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal renal function | Active comparator | Drug: DA-8010eGFR >=90 mL/min/1.73m^2 |
| Mild renal impairment | Experimental | Drug: DA-8010eGFR 60~89 mL/min/1.73m^2 |
| Moderate renal impairment | Experimental | Drug: DA-8010eGFR 30~59 mL/min/1.73m^2 |
| Severe renal impairment | Experimental | Drug: DA-8010eGFR 15~29 mL/min/1.73m^2 |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- [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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DA-8010DA-8010 5mg single dose administration | Drug | Mild renal impairment, Moderate renal impairment, Normal renal function, Severe renal impairment |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DA-8010 in people with Renal Impairment and Healthy, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.