ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02824380
Recruitment Status : Completed
First Posted : July 6, 2016
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Androgenic Alopecia Drug: DA-4001 H Drug: DA-4001 L Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : July 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sequence A
Period 1: DA-4001 H(High dose) Period 2: DA-4001 L(Low dose)
Drug: DA-4001 H
5% minoxidil / high dose of finasteride

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

Experimental: Sequence B
Period 1: DA-4001 L(Low dose) Period 2: DA-4001 H(High dose)
Drug: DA-4001 H
5% minoxidil / high dose of finasteride

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




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824380


Locations
Korea, Republic of
Inje University Busan Paik Hospital
Busan, Korea, Republic of
Sponsors and Collaborators
Dong-A ST Co., Ltd.

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT02824380     History of Changes
Other Study ID Numbers: DA4001_AGAP_I
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical