A Phase 1, Randomized, Multiple Dose, Double Blind, 5-way Crossover Study of the Electrocardiographic Effects of Bilastine in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- QTc Interval prolongation
研究概览
简要总结
The purpose of this study is to evaluate the effect of two doses of bilastine (20 and 100 mg) compared to bilastine 20 mg administered with ketoconazole 400 mg, moxifloxacin 400 mg, and placebo. Subjects will receive each of the five study treatments in a crossover fashion administered once daily for 4 days.
详细描述
This is a single center, Phase 1 study that utilizes a randomized, multiple-dose, double-blind, 5-way crossover design with a placebo control and two active controls. A minimum seven day washout period following four days of dosing for each of the five treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects with no clinically significant findings note on screening assessments including medical history, physical examination and laboratory results
排除标准
- •Clinically significant medical condition
- •Clinically significant history of ECG abnormalities or family history of QTc interval syndrome
- •Use of tobacco and/or nicotine products >3 months prior to screening
- •Use of any prescription medications within 14 days prior to screening
- •Use of over the counter medications (including herbal products) within 7 days prior to screening
研究组 & 干预措施
1
Bilastine 20 mg
干预措施: Bilastine (Drug)
2
Bilastine 100 mg
干预措施: Bilastine (Drug)
3
Bilastine 20 mg + Ketoconazole 400 mg
干预措施: Bilastine & Ketoconazole (Drug)
4
Moxifloxacin 400 mg
干预措施: Moxifloxacin (Drug)
5
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
QTc Interval prolongation
时间窗: 4 days
次要结局
- vital signs, adverse events, and routine clinical laboratory tests(4 days)