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

NCT02824380 | Completed Phase 1

• 1 other identifier: DA4001_AGAP_I
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Androgenic Alopecia

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Change from baseline of testosterone and DHT(ng/mL)

  day1: before administration, day7: before administration and 6, 12, 24h after administration

Secondary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Sequence A

EXPERIMENTAL

Period 1: DA-4001 H(High dose) Period 2: DA-4001 L(Low dose)

Drug: DA-4001 H; Drug: DA-4001 L

Sequence B

EXPERIMENTAL

Period 1: DA-4001 L(Low dose) Period 2: DA-4001 H(High dose)

Drug: DA-4001 H; Drug: DA-4001 L

Interventions

DA-4001 H DRUG

5% minoxidil / high dose of finasteride

Sequence A; Sequence B

DA-4001 L DRUG

5% minoxidil / low dose of finasteride

Sequence A; Sequence B

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, aged between 19 and 65 years, clinically healthy
• BMI between 18.5kg/m2 and 27kg/m2
• Clinical history of Androgenic Alopecia

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

Inje University Busan Paik Hospital

Busan, South Korea

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 6, 2016
• Study Start: July 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: March 30, 2018

Record last verified: 2018-03

Locations

KR (1)