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临床试验/NCT02114671
NCT02114671撤回1 期

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

Boehringer Ingelheim1 个研究点 分布在 1 个国家开始时间: 2014年4月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

capsules, oral administration with 240 ml water, fed conditions

干预措施: Faldaprevir high dose (Drug)

Faldaprevir QD low dose

Experimental

tablets/capsules, oral administration with 240 ml water, fed conditions

干预措施: Faldaprevir low dose (Drug)

Placebo

Placebo Comparator

capsules, oral administration with 240 ml water, fed conditions

干预措施: Placebo (Drug)

Ciprofloxacin

Active Comparator

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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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