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)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Cmax of OPA-15406 in a Single Administration Period
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
0.3% OPA-15406 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 assigned0.3% OPA-15406 ointment assessed until 48 hours postdose.
干预措施: 0.3% OPA-15406 Ointment (Drug)
1% OPA-15406 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 1% OPA-15406 ointment assessed until 48 hours postdose.
干预措施: 1% OPA-15406 Ointment (Drug)
3% OPA-15406 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.
干预措施: 3% OPA-15406 Ointment (Drug)
Placebo 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 placebo ointment assessed until 48 hours postdose.
干预措施: Placebo Ointment (Drug)
0.3% OPA-15406 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.
干预措施: 0.3% OPA-15406 Ointment (Drug)
1% OPA-15406 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.
干预措施: 1% OPA-15406 Ointment (Drug)
3% OPA-15406 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.
干预措施: 3% OPA-15406 Ointment (Drug)
Placebo in the multiple administration period
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.
干预措施: Placebo Ointment (Drug)
结局指标
主要结局
Cmax of OPA-15406 in a Single Administration Period
时间窗: 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
时间窗: 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.
次要结局
- AUC12h of OPA-15406 in a Single Administration Period(Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs)
- AUC12h of OPA-15406 in the Multiple Administration Period(Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs at Day 14)