NCT00509275已完成1 期
A Phase Ib, Randomized, Double Blind, Placebo Controlled Study to Investigate the Pharmacokinetics, Safety and Efficacy of 3 Different Doses of W0027 and Placebo Capsules in Subjects With Clinically and Mycologically Proven MTTP
Stiefel, a GSK Company7 个研究点 分布在 2 个国家目标入组 120 人开始时间: 2007年7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
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 7
- 主要终点
- The primary objective of this study is to assess the subject response to three W0027 regimens in subjects with MTTP.
研究概览
简要总结
In this phase Ib, multi-centre, randomized, double-blind, placebo-controlled parallel group study, 120 subjects with moccasin type tinea pedis (MTTP) will be enrolled at approximately 11 centres in the USA, Canada and Australia.
The primary objective of the study is to assess the patient response to three W0027 regimens in subjects with MTTP. Secondary objectives include assessment of the safety, tolerability and skin and nail pharmacokinetics to the three Albaconazole regimens.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 18-65 years, who have been diagnosed with moccasin type tinea pedis (by positive dermatophyte culture, positive potassium hydroxide/calcofluor white preparation, and a Total Signs and Symptoms Score of at least 4).
- •Females of childbearing potential must use contraceptive methods .
排除标准
- •Subjects who are receiving any CYP3A substrates with potential for QT prolongation;
- •have used systemic antifungal drugs within 30 days of first dose; or topical antifungals within 2 weeks of first dose.
- •Also excluded are those who have a clinically significant medical condition.
研究组 & 干预措施
1
Experimental
W0027
干预措施: W0027 (Drug)
2
Experimental
W0027
干预措施: W0027 (Drug)
3
Experimental
W0027
干预措施: W0027 (Drug)
4
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The primary objective of this study is to assess the subject response to three W0027 regimens in subjects with MTTP.
时间窗: Week 8
次要结局
- The secondary objectives of this study are: To assess the safety and tolerability of three W0027 regimens in subjects with MTTP; To assess skin and nail pharmacokinetics of three Albaconazole doses in subjects with MTTP.(Skin and Plasma samples Week 0 (Visit 2) through to Week 8 (Visit 9), Nail samples Week 0 (Visit 2) Week 4(Visit 7) and Week 8(Visit 9))
研究者
研究点 (7)
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