HealthyPhase 1NCT04013477
Single-ascending Dose Phase 1 Clinical Trial to Evaluate the Safety and PK of DA-5207 TDS in Healthy Adults
A Phase 1 study testing DA-5207 and Donepezil Hydrochloride in people with Healthy, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
A single-blinded, placebo- and active-controlled, parallel, single-ascending dose phase 1 clinical trial to evaluate the safety and pharmacokinetics of DA-5207 transdermal delivery system in healthy adults Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DA-5207 and Donepezil Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Jun 2019to 6 Apr 2020
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Health Male Volunteers (Age : 19~55 years)
- Body Weight : Male≥55kg, Female≥50kg
- 18.5≤BMI<25.0
Who cannot join
- Galactose intolerance, Lapp lactase deficiency, Glucose-galactose malabsorption
- Allergy or Drug hypersensitivity
- Clinically significant Medical History
- AST, ALT > Upper Normal Range*1.25, eGFR<60mL/min/1.73m²
- Heavy alcohol intake (more than 210g/week)
- Heavy smoker (more than 10 cigarettes/day)
- Heavy caffeine intake
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-blinded, Placebo- and Active-controlled, Parallel, Single-ascending Dose Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetics of DA-5207 Transdermal Delivery System in Healthy Adults
A single-blinded, placebo- and active-controlled, parallel, single-ascending dose phase 1 clinical trial to evaluate the safety and pharmacokinetics of DA-5207 transdermal delivery system in healthy adults
- Conditions
- Healthy
- Being tested
- DA-5207, Donepezil Hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-5207Drug
DA-5207 Transdermal Delivery System
Donepezil HydrochlorideDrug
Also called Aricept
donepezil HCl 10mg QD
| Study group | Role | What they receive |
|---|---|---|
| Cohort1 | Experimental | drug : DA-5207 80mg/40cm²
placebo : 40cm² Receives: Drug: DA-5207 |
| Cohort2 | Experimental | drug : DA-5207 120mg/60cm²
placebo : 60cm² Receives: Drug: DA-5207 |
| Cohort3 | Experimental | drug : DA-5207 160mg/80cm²
placebo : 80cm² Receives: Drug: DA-5207 |
| Cohort4 | Active comparator | drug : Aricept Receives: Drug: Donepezil Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
area under the concentration-time curve
Measured: patch : 21days, oral : 11days
Cmax
maximum serum concentration
Measured: patch : 21days, oral : 11days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start18 Jun 2019
- Primary completion5 Dec 2019
- Study completion6 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 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
- NCT04013477
- Sponsor's protocol ID
- DA5207_ADK_Ia
- Status last verified
- Apr 2021
- First submitted
- 26 Jun 2019
- Last updated
- 14 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blinded, Placebo- and Active-controlled, Parallel, Single-ascending Dose Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetics of DA-5207 Transdermal Delivery System in Healthy Adults
- ClinicalTrials.gov ID
- NCT04013477
- Acronym / sponsor ID
- DA5207_ADK_Ia
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- 5 Dec 2019 (actual)
- Study completion
- 6 Apr 2020 (actual)
- First posted
- 9 Jul 2019 (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.
A single-blinded, placebo- and active-controlled, parallel, single-ascending dose phase 1 clinical trial to evaluate the safety and pharmacokinetics of DA-5207 transdermal delivery system in healthy adults
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort1 | Experimental | Drug: DA-5207drug : DA-5207 80mg/40cm² placebo : 40cm² |
| Cohort2 | Experimental | Drug: DA-5207drug : DA-5207 120mg/60cm² placebo : 60cm² |
| Cohort3 | Experimental | Drug: DA-5207drug : DA-5207 160mg/80cm² placebo : 80cm² |
| Cohort4 | Active comparator | Drug: Donepezil Hydrochloridedrug : Aricept |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Health Male Volunteers (Age : 19~55 years)
- Body Weight : Male≥55kg, Female≥50kg
- 18.5≤BMI<25.0
Key exclusion criteria (7 listed)
- Galactose intolerance, Lapp lactase deficiency, Glucose-galactose malabsorption
- Allergy or Drug hypersensitivity
- Clinically significant Medical History
- AST, ALT > Upper Normal Range*1.25, eGFR<60mL/min/1.73m²
- Heavy alcohol intake (more than 210g/week)
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-5207DA-5207 Transdermal Delivery System | Drug | Cohort1, Cohort2, Cohort3 |
| Donepezil HydrochlorideAlso: Ariceptdonepezil HCl 10mg QD | Drug | Cohort4 |
Primary outcome
AUC
Time frame: patch : 21days, oral : 11days
area under the concentration-time curve
Cmax
Time frame: patch : 21days, oral : 11days
maximum serum concentration
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 14 Apr 2021.
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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-5207 and Donepezil Hydrochloride in people with 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 3 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 14 Apr 2021. 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?
AUC (time frame: patch : 21days, oral : 11days). 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 14 Apr 2021.