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

Sponsor
Dong-A ST Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02824380
Collaborator
(none)
14
Enrollment
1
Location
2
Arms
3
Actual Duration (Months)
4.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: DA-4001 H
  • Drug: DA-4001 L
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Actual Study Start Date :
Jul 1, 2016
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Oct 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Css,max(Maximum steady state concentration) of Finasteride(ng/mL) [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) [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) [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) [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) [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) [day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Inje University Busan Paik Hospital Busan Korea, Republic of

Sponsors and Collaborators

  • Dong-A ST Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02824380
Other Study ID Numbers:
  • DA4001_AGAP_I
First Posted:
Jul 6, 2016
Last Update Posted:
Mar 30, 2018
Last Verified:
Mar 1, 2018
Additional relevant MeSH terms:
Alopecia
Alopecia Areata

Study Results

No Results Posted as of Mar 30, 2018