Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects With Androgenic Alopecia

Study Overview
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Brief Summary
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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
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Androgenic Alopecia

Intervention / Treatment
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* Drug: DA-4001 H
* Drug: DA-4001 L


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male, aged between 19 and 65 years, clinically healthy BMI between 18.5kg/m2 and 27kg/m2 Clinical history of Androgenic Alopecia Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br>Period 1: DA-4001 H(High dose) Period 2: DA-4001 L(Low dose) | Drug: DA-4001 H<br>* 5% minoxidil / high dose of finasteride<br>Drug: DA-4001 L<br>* 5% minoxidil / low dose of finasteride<br>|
| Experimental: Sequence B<br>Period 1: DA-4001 L(Low dose) Period 2: DA-4001 H(High dose) | Drug: DA-4001 H<br>* 5% minoxidil / high dose of finasteride<br>Drug: DA-4001 L<br>* 5% minoxidil / low dose of finasteride<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Css,max(Maximum steady state concentration) of Finasteride(ng/mL) |  | 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) |  | 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) |  | day1: before administration, day7: before administration and 6, 12, 24h after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tss,max(Time to reach maximal serum concentrations at steady state)of Finasteride(hr) |  | 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) |  | 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) |  | day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration |