A Randomised, Assessor-blind, Placebo and Active Controlled, Parallel Group Study to Assess the Phototoxic Potential of Faldaprevir (Administered Orally, Once Daily) for 6 Days in Healthy Male and Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of subjects with drug related adverse events
研究概览
简要总结
To investigate the potential of Faldaprevir to induce skin phototoxicity, immediate or delayed type, to UV light and visible light in healthy male and female subjects. To investigate the degree, wavelength dependency, severity, pigmentation and morphology of the phototoxic effects. The persistence of the phototoxic susceptibility will be explored following cessation of study medication. Within a sunscreen sub-study, the efficacy of commercially available high factor sunscreen will also be assessed in terms of its potential to prevent any phototoxic skin responses seen. The safety and tolerability of Faldaprevir will also be assessed.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Faldaprevir QD high dose
capsules, oral administration with 240 ml water, fed conditions
干预措施: Faldaprevir high dose (Drug)
Faldaprevir QD low dose
tablets/capsules, oral administration with 240 ml water, fed conditions
干预措施: Faldaprevir low dose (Drug)
Placebo
capsules, oral administration with 240 ml water, fed conditions
干预措施: Placebo (Drug)
Ciprofloxacin
tablets, oral administration with 240 ml water, fed conditions
干预措施: Ciprofloxacin (Drug)
结局指标
主要结局
Number of subjects with drug related adverse events
时间窗: 17 days
Percentage of subjects with drug related adverse events
时间窗: 17 days
Change in minimum erythema dose (MED) at each wavelength tested, before and during treatment. The change will be quantified by the phototoxic index at 24 hrs (delayed erythema) derived by dividing the baseline MED by that during treatment
时间窗: 7 days
次要结局
- Degree of phototoxic effects by phototoxic index(7 days)
