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

• ClinicalTrials.gov Identifier: NCT02824380
• Recruitment Status: Completed
• First Posted: July 6, 2016
• Last Update Posted: March 30, 2018
• Sponsor: Dong-A ST Co., Ltd.
• Information provided by (Responsible Party): Dong-A ST Co., Ltd.

Tracking Information

• First Submitted Date: June 29, 2016
• First Posted Date: July 6, 2016
• Last Update Posted Date: March 30, 2018
• Actual Study Start Date: July 2016
• Actual Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects With Androgenic Alopecia
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Androgenic Alopecia

Intervention

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

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 1, 2016): 14
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 2016
• Actual Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 19 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT02824380
• Other Study ID Numbers: DA4001_AGAP_I
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dong-A ST Co., Ltd.
• Study Sponsor: Dong-A ST Co., Ltd.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Dong-A ST Co., Ltd.
• Verification Date: March 2018