Back to resultsPharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects With Androgenic Alopecia
Primary Purpose
Androgenic Alopecia
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DA-4001 H
DA-4001 L
Sponsored by
About this trial
This is an interventional treatment trial for Androgenic Alopecia
Eligibility Criteria
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
Sites / Locations
- Inje University Busan Paik Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sequence A
Sequence B
Arm Description
Period 1: DA-4001 H(High dose) Period 2: DA-4001 L(Low dose)
Period 1: DA-4001 L(Low dose) Period 2: DA-4001 H(High dose)
Outcomes
Primary Outcome Measures
Css,max(Maximum steady state concentration) of Finasteride(ng/mL)
AUCtau(Area under the plasma concentration versus time curve) of Finasteride (ng·hr/mL)
Change from baseline of testosterone and DHT(ng/mL)
Secondary Outcome Measures
Tss,max(Time to reach maximal serum concentrations at steady state)of Finasteride(hr)
Css,min(Minimum steady state concentration)of Finasteride(ng/mL)
t1/2β(Elimination Half-life) of Finasteride(hr)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02824380
Brief Title
Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects With Androgenic Alopecia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenic Alopecia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence A
Arm Type
Experimental
Arm Description
Period 1: DA-4001 H(High dose) Period 2: DA-4001 L(Low dose)
Arm Title
Sequence B
Arm Type
Experimental
Arm Description
Period 1: DA-4001 L(Low dose) Period 2: DA-4001 H(High dose)
Intervention Type
Drug
Intervention Name(s)
DA-4001 H
Intervention Description
5% minoxidil / high dose of finasteride
Intervention Type
Drug
Intervention Name(s)
DA-4001 L
Intervention Description
5% minoxidil / low dose of finasteride
Primary Outcome Measure Information:
Title
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
Title
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
Title
Change from baseline of testosterone and DHT(ng/mL)
Time Frame
day1: before administration, day7: before administration and 6, 12, 24h after administration
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Inje University Busan Paik Hospital
City
Busan
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects With Androgenic Alopecia
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