HealthyPhase 1NCT04479865
Phase 1 Clinical Trial to Evaluate the Safety, PK and PD of DA-5207 TDS in Healthy Adults
A Phase 1 study testing Aricept 5mg Tablet, Aricept 10mg Tablet and DA-5207 150mg in people with Healthy, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics 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?
- Aricept 5mg Tablet, Aricept 10mg Tablet and DA-5207 150mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Jul 2020to 30 Apr 2021
- 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 Voulunterrs (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: An Open-label, Randomized, Cross-over, Multiple Dose, Phase 1 Clinical Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of DA-5207 Transdermal Delivery System in Healthy Adults
The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of DA-5207 transdermal delivery system in healthy adults
- Conditions
- Healthy
- Being tested
- Aricept 5mg Tablet, Aricept 10mg Tablet, DA-5207 150mg, DA-5207 170mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aricept 5mg TabletDrug
1 tablet once daily
Aricept 10mg TabletDrug
1 tablet once daily
DA-5207 150mgDrug
1 patch once weekly
DA-5207 170mgDrug
1 patch once weekly
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Period 1, Aricept 5mg → DA-5207 150mg; Period 2, Aricept 5mg → Aricept 10mg Receives: Drug: Aricept 5mg Tablet; Drug: Aricept 10mg Tablet; Drug: DA-5207 150mg |
| Sequence 2 | Experimental | Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 150mg Receives: Drug: Aricept 5mg Tablet; Drug: Aricept 10mg Tablet; Drug: DA-5207 150mg |
| Sequence 3 | Experimental | Period 1, Aricept 5mg → DA-5207 170mg; Period 2, Aricept 5mg → Aricept 10mg Receives: Drug: Aricept 5mg Tablet; Drug: Aricept 10mg Tablet; Drug: DA-5207 170mg |
| Sequence 4 | Experimental | Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 170mg Receives: Drug: Aricept 5mg Tablet; Drug: Aricept 10mg Tablet; Drug: DA-5207 170mg |
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: 29-36 days
Css,max
maximum serum concentration at steady state
Measured: 0-36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start28 Jul 2020
- Primary completion9 Dec 2020
- Study completion30 Apr 2021 (estimated)
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 49 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
- NCT04479865
- Sponsor's protocol ID
- DA5207_AD_Ib
- Status last verified
- Apr 2021
- First submitted
- 12 Jul 2020
- Last updated
- 15 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 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Cross-over, Multiple Dose, Phase 1 Clinical Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of DA-5207 Transdermal Delivery System in Healthy Adults
- ClinicalTrials.gov ID
- NCT04479865
- Acronym / sponsor ID
- DA5207_AD_Ib
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 9 Dec 2020 (actual)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 21 Jul 2020 (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.
The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of DA-5207 transdermal delivery system in healthy adults
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Aricept 5mg Tablet, Drug: Aricept 10mg Tablet, Drug: DA-5207 150mgPeriod 1, Aricept 5mg → DA-5207 150mg; Period 2, Aricept 5mg → Aricept 10mg |
| Sequence 2 | Experimental | Drug: Aricept 5mg Tablet, Drug: Aricept 10mg Tablet, Drug: DA-5207 150mgPeriod 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 150mg |
| Sequence 3 | Experimental | Drug: Aricept 5mg Tablet, Drug: Aricept 10mg Tablet, Drug: DA-5207 170mgPeriod 1, Aricept 5mg → DA-5207 170mg; Period 2, Aricept 5mg → Aricept 10mg |
| Sequence 4 | Experimental | Drug: Aricept 5mg Tablet, Drug: Aricept 10mg Tablet, Drug: DA-5207 170mgPeriod 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 170mg |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Health Voulunterrs (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 |
|---|---|---|
| Aricept 5mg Tablet1 tablet once daily | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Aricept 10mg Tablet1 tablet once daily | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| DA-5207 150mg1 patch once weekly | Drug | Sequence 1, Sequence 2 |
| DA-5207 170mg1 patch once weekly | Drug | Sequence 3, Sequence 4 |
Primary outcome
AUC
Time frame: 29-36 days
area under the concentration-time curve
Css,max
Time frame: 0-36 days
maximum serum concentration at steady state
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 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 Aricept 5mg Tablet, Aricept 10mg Tablet and DA-5207 150mg 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: status not confirmed, as of the sponsor's last update on 15 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?
Results are not available in the source record.
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: 29-36 days). 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 15 Apr 2021.