Androgenic AlopeciaPhase 1NCT02824380
Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects With Androgenic Alopecia
A Phase 1 study testing DA-4001 H and DA-4001 L in people with Androgenic Alopecia, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects with Androgenic Alopecia. Read more about this study
- Who is it for?
- Ages 19 to 65 years, men only
- Conditions the study is for
- Androgenic Alopecia
- What is being tested?
- DA-4001 H and DA-4001 L
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2016to Oct 2016
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, aged between 19 and 65 years, clinically healthy
- BMI between 18.5kg/m2 and 27kg/m2
- Clinical history of Androgenic Alopecia
Who cannot join
- Subject has any dermatological disorders of the scalp
- Subject has a history of hair transplants, hair weaves
- Subject has hypersensitivity to previously prescribed minoxidil or finasteride
- Subject who is considered inappropriate to participate in the study due to any conditions including screening results at the investigator's discretion
Trial locations and contacts
1 site in 1 country.
About this study
An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects with Androgenic Alopecia.
- Conditions
- Androgenic Alopecia
- Being tested
- DA-4001 H, DA-4001 L
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-4001 HDrug
5% minoxidil / high dose of finasteride
DA-4001 LDrug
5% minoxidil / low dose of finasteride
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Period 1: DA-4001 H(High dose) Period 2: DA-4001 L(Low dose) Receives: Drug: DA-4001 H; Drug: DA-4001 L |
| Sequence B | Experimental | Period 1: DA-4001 L(Low dose) Period 2: DA-4001 H(High dose) Receives: Drug: DA-4001 H; Drug: DA-4001 L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Css,max(Maximum steady state concentration) of Finasteride(ng/mL)
Measured: day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration
AUCtau(Area under the plasma concentration versus time curve) of Finasteride (ng·hr/mL)
Measured: day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration
Change from baseline of testosterone and DHT(ng/mL)
Measured: day1: before administration, day7: before administration and 6, 12, 24h after administration
Secondary outcomes (3)
Tss,max(Time to reach maximal serum concentrations at steady state)of Finasteride(hr)
Measured: day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration
Css,min(Minimum steady state concentration)of Finasteride(ng/mL)
Measured: day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration
t1/2β(Elimination Half-life) of Finasteride(hr)
Measured: day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenic AlopeciaStudies 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
- 14 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
- NCT02824380
- Sponsor's protocol ID
- DA4001_AGAP_I
- Status last verified
- Mar 2018
- First submitted
- 29 Jun 2016
- Last updated
- 30 Mar 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects With Androgenic Alopecia
- ClinicalTrials.gov ID
- NCT02824380
- Acronym / sponsor ID
- DA4001_AGAP_I
- Conditions
- Androgenic Alopecia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 6 Jul 2016 (estimated)
- 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.
An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects with Androgenic Alopecia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: DA-4001 H, Drug: DA-4001 LPeriod 1: DA-4001 H(High dose) Period 2: DA-4001 L(Low dose) |
| Sequence B | Experimental | Drug: DA-4001 H, Drug: DA-4001 LPeriod 1: DA-4001 L(Low dose) Period 2: DA-4001 H(High dose) |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male, aged between 19 and 65 years, clinically healthy
- BMI between 18.5kg/m2 and 27kg/m2
- Clinical history of Androgenic Alopecia
Key exclusion criteria (4 listed)
- Subject has any dermatological disorders of the scalp
- Subject has a history of hair transplants, hair weaves
- Subject has hypersensitivity to previously prescribed minoxidil or finasteride
- Subject who is considered inappropriate to participate in the study due to any conditions including screening results at the investigator's discretion
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-4001 H5% minoxidil / high dose of finasteride | Drug | Sequence A, Sequence B |
| DA-4001 L5% minoxidil / low dose of finasteride | Drug | Sequence A, Sequence B |
Primary outcome
Css,max(Maximum steady state concentration) of Finasteride(ng/mL)
Time frame: day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration
AUCtau(Area under the plasma concentration versus time curve) of Finasteride (ng·hr/mL)
Time frame: day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration
Change from baseline of testosterone and DHT(ng/mL)
Time frame: day1: before administration, day7: before administration and 6, 12, 24h after administration
3 secondary outcomes
Tss,max(Time to reach maximal serum concentrations at steady state)of Finasteride(hr)
Time frame: day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration
Css,min(Minimum steady state concentration)of Finasteride(ng/mL)
Time frame: day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration
t1/2β(Elimination Half-life) of Finasteride(hr)
Time frame: day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration
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 30 Mar 2018.
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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-4001 H and DA-4001 L in people with Androgenic Alopecia, 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 4 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 30 Mar 2018. 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?
Css,max(Maximum steady state concentration) of Finasteride(ng/mL) (time frame: day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration). The study lists 3 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 30 Mar 2018.