Pharmacokinetics and Pharmacodynamics of Calcitriol 3 mcg/g Ointment Applied Twice Daily for 14 Days Under Conditions of Maximal Use in Pediatric Subjects (2 to 12 Years of Age) With Plaque Psoriasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 18
- 试验地点
- 8
- 主要终点
- Tmax of Calcitriol Plasma Level
研究概览
简要总结
The purpose of this study is to determine if the calcitriol absorption in pediatric subjects is comparable to that in adults and adolescents, with no significant impact on calcium/phosphorus metabolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female pediatric subjects, 2 to 12 years of age inclusive at screening
- •Clinical diagnosis of plaque type psoriasis involving 3% through 35% body surface area at screening and baseline (excluding face and scalp)
排除标准
- •Subjects with guttate or pustular psoriasis, erythrodermic psoriasis or active infection
- •Vitamin D deficiency at screening
- •Subjects with hypercalcemia and out of range urinary calcium/creatinine ratio at screening
- •Subjects with secondary hyperparathyroidism at screening
研究组 & 干预措施
Calcitriol 3 mcg/g ointment
Topical application every 12 hours for 14 consecutive days
干预措施: Calcitriol 3 mcg/g ointment (Drug)
结局指标
主要结局
Tmax of Calcitriol Plasma Level
时间窗: Day 14
Tmax of calcitriol plasma level at Day 14
AUC (0-6h) of Calcitriol Plasma Level
时间窗: Day 14
AUC (0-6h) of calcitriol plasma level at Day 14 (Pre-dose to 6 hours post-dose)
AUC (0-9h) of Calcitriol Plasma Level
时间窗: Day 14
AUC (0-9h) of calcitriol plasma level at Day 14 (Pre-dose to 9 hours post-dose. For subjects with a body weight of \<15 kg, AUC (0-9h) was extrapolated based on the pre-dose to 6 hours post-dose PK samples.)
AUC (0-12h) of Calcitriol Plasma Level
时间窗: Day 14
AUC (0-12h) of calcitriol plasma level at Day 14 (For subjects with a body weight of \< 15 kg, AUC (0-9h) was extrapolated based on the pre-dose to 6 hours post dose PK samples. For subjects with a body weight of ≥ 15 kg, AUC (0-12h) was extrapolated based on the pre-dose to 9 hours post-dose PK samples.)
Cmax of Calcitriol Plasma Level
时间窗: Day 14
Cmax of calcitriol plasma level at Day 14 (Peak plasma concentration of calcitriol from Day 1 to Day 14)
Cmin of Calcitriol Plasma Level
时间窗: Day 14
Cmin of calcitriol plasma level at Day 14
次要结局
未报告次要终点