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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: 0.3% OPA-15406 Ointment
* Drug: 1% OPA-15406 Ointment
* Drug: 3% OPA-15406 Ointment
* Drug: Placebo Ointment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.3% OPA-15406 in a single administration period<br>32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned0.3% OPA-15406 ointment assessed until 48 hours postdose. | Drug: 0.3% OPA-15406 Ointment<br>* 32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 0.3 % OPA-15406 ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.<br>* Other names: OPA-15406 Ointment;|
| Experimental: 1% OPA-15406 in a single administration period<br>32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 1% OPA-15406 ointment assessed until 48 hours postdose. | Drug: 1% OPA-15406 Ointment<br>* 32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 1 % OPA-15406 ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned 1% OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose<br>* Other names: OPA-15406 Ointment;|
| Experimental: 3% OPA-15406 in a single administration period<br>32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 3% OPA-15406 ointment assessed until 48 hours postdose. | Drug: 3% OPA-15406 Ointment<br>* 32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 3 % OPA-15406 ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned 3% OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.<br>* Other names: OPA-15406 Ointment;|
| Placebo Comparator: Placebo in a single administration period<br>32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned placebo ointment assessed until 48 hours postdose. | Drug: Placebo Ointment<br>* 32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration periodriod, subjects were treated with assigned placebo ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned placebo ointment twice daily for 14 days and assessed until 48 hours post dose.<br>|
| Experimental: 0.3% OPA-15406 in the multiple administration period<br>In the multiple administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose. | Drug: 0.3% OPA-15406 Ointment<br>* 32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 0.3 % OPA-15406 ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.<br>* Other names: OPA-15406 Ointment;|
| Experimental: 1% OPA-15406 in the multiple administration period<br>In the multiple administration period, same subjects were treated with assigned 1% OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose. | Drug: 1% OPA-15406 Ointment<br>* 32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 1 % OPA-15406 ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned 1% OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose<br>* Other names: OPA-15406 Ointment;|
| Experimental: 3% OPA-15406 in the multiple administration period<br>In the multiple administration period, same subjects were treated with assigned 3% OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose. | Drug: 3% OPA-15406 Ointment<br>* 32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 3 % OPA-15406 ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned 3% OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.<br>* Other names: OPA-15406 Ointment;|
| Experimental: Placebo in the multiple administration period<br>In the multiple administration period, same subjects were treated with assigned OPA-15406 ointment placebo twice daily for 14 days and assessed until 48 hours post dose. | Drug: Placebo Ointment<br>* 32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration periodriod, subjects were treated with assigned placebo ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned placebo ointment twice daily for 14 days and assessed until 48 hours post dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of OPA-15406 in a Single Administration Period | We measure the plasma concentration of OPA-15406 at Day 1 by applying 0.3%, 1%, or 3% formulation of OPA-15406 ointment as a single dose. We assess the Cmax of OPA-15406. | Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hr | 
| Cmax of OPA-15406 in the Multiple Administration Period | We measure the plasma concentration of OPA-15406 from Day 1 to Day 14 by applying 0.3%, 1%, or 3% formulation of OPA-15406 ointment as multiple doses twice daily for 2 weeks. We assess the AUC12h x of OPA-15406. | Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs at Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC12h of OPA-15406 in a Single Administration Period | We measure the plasma concentration of OPA-15406 at Day 1 by applying 0.3%, 1%, or 3% formulation of OPA-15406 ointment as a single dose. We assess the AUC12h x of OPA-15406. | Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs | 
| AUC12h of OPA-15406 in the Multiple Administration Period | We measure the plasma concentration of OPA-15406 from Day 1 to Day 14 by applying 0.3%, 1%, or 3% formulation of OPA-15406 ointment as multiple doses twice daily for 2 weeks. We assess the AUC12h x of OPA-15406. | Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs at Day 14 |