Atopic Dermatitis
Conditions
Brief 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.
Interventions
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.
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
DRUG3% OPA-15406 Ointment
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.
DRUGPlacebo Ointment
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.
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of OPA-15406 in a Single Administration Period | Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hr | 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. |
| Cmax of OPA-15406 in the Multiple Administration Period | Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs at Day 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC12h of OPA-15406 in a Single Administration Period | Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs | 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. |
| AUC12h of OPA-15406 in the Multiple Administration Period | Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs at Day 14 | 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| 1% OPA-15406 Ointment In a single administration period and the multiple administration period, same subjects were treated with assigned 1% OPA-15406 ointment. | 8 |
| 3% OPA-15406 Ointment In a single administration period and the multiple administration period, same subjects were treated with assigned 3% OPA-15406 ointment. | 8 |
| Placebo In a single administration period and the multiple administration period, same subjects were treated with assigned placebo ointment. | 8 |
| Total | 32 |
Baseline characteristics
| Characteristic | Total | 0.3% OPA-15406 Ointment | 1% OPA-15406 Ointment | 3% OPA-15406 Ointment | Placebo |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants |
| Age, Continuous | 30.0 years STANDARD_DEVIATION 6.8 | 31.9 years STANDARD_DEVIATION 7.2 | 28.3 years STANDARD_DEVIATION 7.6 | 30.5 years STANDARD_DEVIATION 6.7 | 29.5 years STANDARD_DEVIATION 6.3 |
| Region of Enrollment Japan | 32 participants | 8 participants | 8 participants | 8 participants | 8 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 32 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 |
Outcome results
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.
Time frame: Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hr
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.3% OPA-15406 Ointment in a Single Administration Period | Cmax of OPA-15406 in a Single Administration Period | 0.508 ng/mL | Standard Deviation 0.304 |
| 1% OPA-15406 Ointment in a Single Administration Period | Cmax of OPA-15406 in a Single Administration Period | 0.838 ng/mL | Standard Deviation 0.531 |
| 3% OPA-15406 Ointment in a Single Administration Period | Cmax of OPA-15406 in a Single Administration Period | 1.61 ng/mL | Standard Deviation 0.835 |
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.
Time frame: Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs at Day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.3% OPA-15406 Ointment in a Single Administration Period | Cmax of OPA-15406 in the Multiple Administration Period | 0.506 ng/mL | Standard Deviation 0.348 |
| 1% OPA-15406 Ointment in a Single Administration Period | Cmax of OPA-15406 in the Multiple Administration Period | 0.795 ng/mL | Standard Deviation 0.208 |
| 3% OPA-15406 Ointment in a Single Administration Period | Cmax of OPA-15406 in the Multiple Administration Period | 1.65 ng/mL | Standard Deviation 0.462 |
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.
Time frame: Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.3% OPA-15406 Ointment in a Single Administration Period | AUC12h of OPA-15406 in a Single Administration Period | 3.74 ng･h/mL | Standard Deviation 2.32 |
| 1% OPA-15406 Ointment in a Single Administration Period | AUC12h of OPA-15406 in a Single Administration Period | 6.42 ng･h/mL | Standard Deviation 4.86 |
| 3% OPA-15406 Ointment in a Single Administration Period | AUC12h of OPA-15406 in a Single Administration Period | 11.2 ng･h/mL | Standard Deviation 6.24 |
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.
Time frame: Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs at Day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.3% OPA-15406 Ointment in a Single Administration Period | AUC12h of OPA-15406 in the Multiple Administration Period | 4.65 ng･h/mL | Standard Deviation 3.07 |
| 1% OPA-15406 Ointment in a Single Administration Period | AUC12h of OPA-15406 in the Multiple Administration Period | 7.84 ng･h/mL | Standard Deviation 1.78 |
| 3% OPA-15406 Ointment in a Single Administration Period | AUC12h of OPA-15406 in the Multiple Administration Period | 16.6 ng･h/mL | Standard Deviation 4.99 |