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

March 29, 2018 updated by: Dong-A ST Co., Ltd.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
day1: before administration, day7: before administration and 6, 12, 24h after administration

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2016

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

June 29, 2016

First Submitted That Met QC Criteria

July 1, 2016

First Posted (ESTIMATE)

July 6, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 30, 2018

Last Update Submitted That Met QC Criteria

March 29, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA4001_AGAP_I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Androgenic Alopecia

Clinical Trials on DA-4001 H

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe