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Completed

NCT Number: NCT02824380

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

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.

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Key information

Conditions

Androgenic Alopecia Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Inje University Busan Paik Hospital

Busan, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DA-4001 H

Drug

5% minoxidil / high dose of finasteride

DA-4001 L

Drug

5% minoxidil / low dose of finasteride

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 6, 2016
Registry last updated
Mar 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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