Androgenetic AlopeciaPhase 1NCT04214808
To Evaluate the Pharmacokinetics and Safety of AD-208
A Phase 1 study testing AD-208 and Avodart Soft Capsule 0.5mg in people with Androgenetic Alopecia, run by Addpharma Inc. at 1 site in South Korea.
Trial summary
To evaluate pharmacokinetics and safety of AD-208. Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- AD-208 and Avodart Soft Capsule 0.5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jan 2020to 4 May 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male Adult aged between 19 to 50 at the time of screening visit
- Weight over 50kg and Body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2 at the time of screening visit
- No evidence of medical symptoms or signs of congenital or no chronic disease
Who cannot join
- If having a clinically significant disease or medical history for blood/tumor, genitourinary systen, liver/biliary system, kidney, respiratory system, alimentary system, endocrine system, immune system, cardiovascular system, nervous system, skin and psychical disorder, etc
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of AD-208
To evaluate pharmacokinetics and safety of AD-208.
Read the detailed description
The purpose is that pharmacokinetics and safety of AD-208 in healthy adult male volunteers are evaluated as compared to Avodart Soft Capsule 0.5mg.
- Conditions
- Androgenetic Alopecia
- Being tested
- AD-208, Avodart Soft Capsule 0.5mg
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD-208Drug
Dutasteride 0.2mg
Avodart Soft Capsule 0.5mgDrug
Dutasteride 0.5mg
| Study group | Role | What they receive |
|---|---|---|
| Avodart Soft Capsule 0.5mg to AD-208 | Experimental | Period 1: Avodart Soft Capsule 0.5mg, 1 Capsule Period 2: AD-208, 1 tab Receives: Drug: AD-208; Drug: Avodart Soft Capsule 0.5mg |
| AD-208 to Avodart Soft Capsule 0.5mg | Experimental | Period 1: AD-208, 1 tab Period 2: Avodart Soft Capsule 0.5mg, 1 Capsule Receives: Drug: AD-208; Drug: Avodart Soft Capsule 0.5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve in time plot (AUCt)
AUCt of the total ingredient of dutasteride
Measured: Pre-dose(0 hour) to 72 hour
Peak Plasma Concentration (Cmax)
Cmax of the total ingredient of dutasteride
Measured: Pre-dose(0 hour) to 72 hour
Secondary outcomes (5)
Area under the curve in time plot (AUCinf)
AUCinf of the total ingredient of dutasteride
Measured: Pre-dose(0 hour) to 72 hour
Time to reach Cmax(Tmax)
Tmax of the total ingredient of dutasteride
Measured: Pre-dose(0 hour) to 72 hour
Effective half-life(t1/2)
t1/2 of the total ingredient of dutasteride
Measured: Pre-dose(0 hour) to 72 hour
Clearance(CL/F)
CL/F of the total ingredient of dutasteride
Measured: Pre-dose(0 hour) to 72 hour
Volume of distribution(Vd/F)
Vd/F of the total ingredient of dutasteride
Measured: Pre-dose(0 hour) to 72 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start3 Jan 2020
- Primary completion4 Feb 2020
- Study completion4 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- More trials run by Addpharma Inc.The sponsor's other registered studies.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addpharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Young-Ran Yoon, M.D., Ph.D, Principal investigator, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214808
- Sponsor's protocol ID
- AD-208PK
- Status last verified
- Dec 2020
- First submitted
- 26 Dec 2019
- Last updated
- 2 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of AD-208
- ClinicalTrials.gov ID
- NCT04214808
- Acronym / sponsor ID
- AD-208PK
- Conditions
- Androgenetic Alopecia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 4 Feb 2020 (actual)
- Study completion
- 4 May 2020 (actual)
- First posted
- 2 Jan 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.
To evaluate pharmacokinetics and safety of AD-208.
Detailed description
The purpose is that pharmacokinetics and safety of AD-208 in healthy adult male volunteers are evaluated as compared to Avodart Soft Capsule 0.5mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avodart Soft Capsule 0.5mg to AD-208 | Experimental | Drug: AD-208, Drug: Avodart Soft Capsule 0.5mgPeriod 1: Avodart Soft Capsule 0.5mg, 1 Capsule Period 2: AD-208, 1 tab |
| AD-208 to Avodart Soft Capsule 0.5mg | Experimental | Drug: AD-208, Drug: Avodart Soft Capsule 0.5mgPeriod 1: AD-208, 1 tab Period 2: Avodart Soft Capsule 0.5mg, 1 Capsule |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male Adult aged between 19 to 50 at the time of screening visit
- Weight over 50kg and Body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2 at the time of screening visit
- No evidence of medical symptoms or signs of congenital or no chronic disease
Key exclusion criteria (1 listed)
- If having a clinically significant disease or medical history for blood/tumor, genitourinary systen, liver/biliary system, kidney, respiratory system, alimentary system, endocrine system, immune system, cardiovascular system, nervous system, skin and psychical disorder, etc
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 |
|---|---|---|
| AD-208Dutasteride 0.2mg | Drug | AD-208 to Avodart Soft Capsule 0.5mg, Avodart Soft Capsule 0.5mg to AD-208 |
| Avodart Soft Capsule 0.5mgDutasteride 0.5mg | Drug | AD-208 to Avodart Soft Capsule 0.5mg, Avodart Soft Capsule 0.5mg to AD-208 |
Primary outcome
Area under the curve in time plot (AUCt)
Time frame: Pre-dose(0 hour) to 72 hour
AUCt of the total ingredient of dutasteride
Peak Plasma Concentration (Cmax)
Time frame: Pre-dose(0 hour) to 72 hour
Cmax of the total ingredient of dutasteride
5 secondary outcomes
Area under the curve in time plot (AUCinf)
Time frame: Pre-dose(0 hour) to 72 hour
Time to reach Cmax(Tmax)
Time frame: Pre-dose(0 hour) to 72 hour
Effective half-life(t1/2)
Time frame: Pre-dose(0 hour) to 72 hour
Clearance(CL/F)
Time frame: Pre-dose(0 hour) to 72 hour
Volume of distribution(Vd/F)
Time frame: Pre-dose(0 hour) to 72 hour
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 2 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Androgenetic Alopecia
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Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
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Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
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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.
Young-Ran Yoon, M.D., Ph.D principal investigator
Kyungpook National University Hospital
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 AD-208 and Avodart Soft Capsule 0.5mg in people with Androgenetic Alopecia, run by Addpharma Inc. 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 1 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 2 Dec 2020. 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 curve in time plot (AUCt) (time frame: Pre-dose(0 hour) to 72 hour). 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 2 Dec 2020.