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

Androgenic Alopecia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02824380
• Other study ID #: DA4001_AGAP_I
• Status: Completed
• Phase: Phase 1
• First received: June 29, 2016
• Last updated: March 29, 2018
• Start date: July 2016
• Est. completion date: October 2016

Study information

• Verified date: March 2018
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenic Alopecia

Intervention

Drug:
• DA-4001 H
5% minoxidil / high dose of finasteride
• DA-4001 L
5% minoxidil / low dose of finasteride

Locations

Country	Name	City	State
Korea, Republic of	Inje University Busan Paik Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change from baseline of testosterone and DHT(ng/mL)		day1: before administration, day7: before administration and 6, 12, 24h after administration
Secondary	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
Secondary	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
Secondary	t1/2ß(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