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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.3% OPA-15406 in a single administration period | Experimental | 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. |
|
| 1% OPA-15406 in a single administration period | Experimental | 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. |
|
| 3% OPA-15406 in a single administration period | Experimental | 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. |
|
| Placebo in a single administration period | Placebo Comparator | 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. |
|
| 0.3% OPA-15406 in the multiple administration period |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.3% OPA-15406 Ointment | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hiroaki Ono, Mr | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanto Region | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.3% OPA-15406 Ointment | In a single administration period and the multiple administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment. |
| FG001 | 1% OPA-15406 Ointment | In a single administration period and the multiple administration period, same subjects were treated with assigned 1% OPA-15406 ointment. |
| FG002 | 3% OPA-15406 Ointment | In a single administration period and the multiple administration period, same subjects were treated with assigned 3% OPA-15406 ointment. |
| FG003 | Placebo | In a single administration period and the multiple administration period, same subjects were treated with assigned placebo ointment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.3% OPA-15406 Ointment | In a single administration period and the multiple administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment. |
| BG001 | 1% OPA-15406 Ointment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | ng/mL | Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hr |
|
A single administration: From date of informed consent to 48 hours post dose The multiple administration: From date of assigned IMP twice daily to 16 days post dose
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.3 % OPA-15406 Ointment in a Single Administration Period | 32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director, Department of Clinical Management | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Experimental |
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. |
|
| 1% OPA-15406 in the multiple administration period | Experimental | 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. |
|
| 3% OPA-15406 in the multiple administration period | Experimental | 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. |
|
| Placebo in the multiple administration period | Experimental | 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. |
|
|
|
| 1% OPA-15406 Ointment | Drug | 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 |
|
|
| 3% OPA-15406 Ointment | Drug | 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. |
|
|
| Placebo Ointment | Drug | 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. |
|
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 |
In a single administration period and the multiple administration period, same subjects were treated with assigned 1% OPA-15406 ointment.
| BG002 | 3% OPA-15406 Ointment | In a single administration period and the multiple administration period, same subjects were treated with assigned 3% OPA-15406 ointment. |
| BG003 | Placebo | In a single administration period and the multiple administration period, same subjects were treated with assigned placebo ointment. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 3% OPA-15406 Ointment in a Single Administration Period | 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. |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | ng/mL | Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs at Day 14 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | ng･h/mL | Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | ng･h/mL | Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs at Day 14 |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | 1% OPA-15406 Ointment in a Single Administaration Period | 32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single and administration period, same subjects were treated with assigned 1% OPA-15406 ointment. | 0 | 8 | 0 | 8 |
| EG002 | 3% OPA-15406 Ointment in a Single Administaration Period | 32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, same subjects were treated with assigned 3% OPA-15406 ointment. | 0 | 8 | 0 | 8 |
| EG003 | Placebo in a Single Adminstaration Period | 32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, same subjects were treated with assigned placebo ointment. | 0 | 8 | 0 | 8 |
| EG004 | 0.3 % OPA-15406 Ointment in the Multiple Administration Period | 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. | 0 | 8 | 0 | 8 |
| EG005 | 1 % OPA-15406 Ointment in the Multiple Administration Period | 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. | 0 | 8 | 0 | 8 |
| EG006 | 3 % OPA-15406 Ointment in the Multiple Administration Period | 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. | 0 | 8 | 0 | 8 |
| EG007 | Placebo Ointment in the Multiple Administration Period | 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. | 0 | 8 | 0 | 8 |
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |