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

Phase 1

Completed

• Conditions: Androgenic Alopecia
• Interventions: Drug: DA-4001 H; Drug: DA-4001 L

• Registration Number: NCT02824380
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-29
• Study Start: 2016-07
• Study First Submitted QC: 2016-07-01
• Study First Posted: 2016-07-06
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-29
• Last Update Posted: 2018-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A	DA-4001 L	Period 1: DA-4001 H(High dose) Period 2: DA-4001 L(Low dose)
Sequence B	DA-4001 H	Period 1: DA-4001 L(Low dose) Period 2: DA-4001 H(High dose)
Sequence B	DA-4001 L	Period 1: DA-4001 L(Low dose) Period 2: DA-4001 H(High dose)
Sequence A	DA-4001 H	Period 1: DA-4001 H(High dose) Period 2: DA-4001 L(Low dose)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Inje University Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of