PK and PD of Calcitriol Following Twice Daily Application of Calcitriol 3 µg/g Ointment Under Conditions of Maximal Use in Adolescents With Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 25
- 试验地点
- 7
- 主要终点
- Trough Plasma Levels (Ctrough) of Calcitriol
研究概览
简要总结
This is an open-label, multicenter study to assess the systemic exposure to calcitriol in the adolescent population. Calcitriol 3µg/g ointment (2 mg/cm² per application) is to be applied twice daily to involved skin (10 - 35% BSA involved, excluding face, scalp and intertriginous areas) for 56 days (8 weeks). Full Pharmacokinetic (PK) and Pharmacodynamic (PD) profile will be collected during the first 3 weeks of the study; safety and efficacy data will be collected for the 8 weeks of the treatment.
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic plaque psoriasis
- •10 - 35% BSA of involved skin
- •Age 12 - 17
排除标准
- •Other type of psoriasis (other than plaque)
- •Significant abnormal lab findings
- •Vit D insufficiency
研究组 & 干预措施
Calcitriol 3mcg/g
Participants receive calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.
干预措施: Calcitriol 3mcg/g (Drug)
结局指标
主要结局
Trough Plasma Levels (Ctrough) of Calcitriol
时间窗: Day 0 (Baseline), Day 14, Day 21, and Day 56
Trough plasma levels (Ctrough) of calcitriol was reported.
Area Under the Concentration-Time Curve From Pre-Application (T0) Through 12 Hours Post Dosing (AUC [0-12 Hours])
时间窗: 0 (predose) and 12 hours post dose on Day 0 (Baseline), Day 21
The AUC(0-12 hours) that is area under the plasma concentration-time curve from time 0 to 12 hours after dosing was reported.
The Observed Peak Drug Concentration (Cmax) of Calcitriol
时间窗: Day 0 (Baseline), Day 21
Cmax of calcitriol was reported.
Area Under the Concentration-Time Curve From Pre-Application (T0) Through 9 Hours Post Dosing (AUC [0-9 Hours])
时间窗: 0 (predose) and 9 hours post dose on Day 0 (Baseline), Day 21
The AUC(0-9 hours) that is area under the plasma concentration-time curve from time 0 to 9 hours after dosing was reported.
Time at Which Maximum Concentration (Cmax) Occurred (Tmax)
时间窗: Day 0 (Baseline), Day 21
Tmax is the time to reach maximum concentration and was reported for calcitriol.
次要结局
- Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium, Urinary (U) Calcium Random) and Phosphorus Homeostasis up to Day 56(From baseline (Day 0) up to Day 56)
- Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium Albumin Adjusted) Homeostasis up to Day 56(From baseline (Day 0) up to Day 56)
- Change From Baseline in Effect of Calcitriol Ointment on Calcium (Urinary Calcium/Creatinine Ratio) Homeostasis up to Day 56(From baseline (Day 0) up to Day 56)
- Number of Participants With Adverse Events(From start of the study to Day 56)