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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.

Tracking Information
First Submitted Date  ICMJE June 29, 2016
First Posted Date  ICMJE July 6, 2016
Last Update Posted Date March 30, 2018
Actual Study Start Date  ICMJE July 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2016)
  • 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 ]
  • 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 ]
  • Change from baseline of testosterone and DHT(ng/mL) [ Time Frame: day1: before administration, day7: before administration and 6, 12, 24h after administration ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2016)
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2016)
  • 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 ]
  • Css,min(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 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects With Androgenic Alopecia
Official Title  ICMJE Not Provided
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Androgenic Alopecia
Intervention  ICMJE
  • Drug: DA-4001 H
    5% minoxidil / high dose of finasteride
  • Drug: DA-4001 L
    5% minoxidil / low dose of finasteride
Study Arms  ICMJE
  • Experimental: Sequence A
    Period 1: DA-4001 H(High dose) Period 2: DA-4001 L(Low dose)
    Interventions:
    • Drug: DA-4001 H
    • Drug: DA-4001 L
  • Experimental: Sequence B
    Period 1: DA-4001 L(Low dose) Period 2: DA-4001 H(High dose)
    Interventions:
    • Drug: DA-4001 H
    • Drug: DA-4001 L
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2016)
14
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02824380
Other Study ID Numbers  ICMJE DA4001_AGAP_I
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dong-A ST Co., Ltd.
Study Sponsor  ICMJE Dong-A ST Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Dong-A ST Co., Ltd.
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP