A Phase 1 Trial of OPA-15406 Ointment in Healthy Adult Male Subjects

Atopic Dermatitis Clinical Trial

Official title:

A Single-center, Placebo-controlled, Randomized, Double-blind, Parallel-group Comparison Trial to Assess the Safety and Pharmacokinetics of OPA-15406 Ointment in Healthy Adult Male Subjects (Phase 1 Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02334787
• Other study ID #: 271-14-001
• Status: Completed
• Phase: Phase 1
• First received: January 5, 2015
• Last updated: August 10, 2015
• Start date: January 2015
• Est. completion date: February 2015

Study information

• Verified date: August 2015
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

To assess the safety (especially skin findings) and pharmacokinetics by applying 0.3%, 1%, or 3% formulation of 5g OPA-15406 ointment to a 1000 cm2 area as a single-dose and as a multiple-dose twice daily for 2 weeks in Japanese healthy adult male subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• BMI = Body weight (kg) / [Height (m)]2: at least 18.5 and less than 25.0

• Judged by the investigator or subinvestigator to be healthy based on test results at screening and prior to administration on Day 1 of the treatment period

Exclusion Criteria:

• Findings (sunburn, abrasions, tattoos, etc) on the back that affect the evaluation of the safety of the skin

• Judged by the investigator or subinvestigator as inappropriate to participate in this trial for any other reasons

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• 0.3% OPA-15406 Ointment

• 1% OPA-15406 Ointment

• 3% OPA-15406 Ointment

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		A single-dose and a multiple-dose twice daily (every 12 hours) for 2 weeks	Yes
Secondary	Cmax of OPA-15406		Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs	No
Secondary	AUC of OPA-15406		Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs	No