An Open-label, Single-sequence Study to Evaluate the Effect of Azithromycin on BCT197 Exposure in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration-time curve (AUC) BCT197 in the presence and absence of Azithromycin.
研究概览
简要总结
An open-label, single-sequence study to evaluate the effect of azithromycin on BCT197 exposure in healthy male subjects.
详细描述
This will be an open study conducted in healthy male subjects at a single centre. Each subject will participate in a screening visit and 2 study periods. At the first study period, all subjects will receive a single dose of BCT197 and at study period 2, all subjects will receive 3 daily doses of azithromycin and a single dose of BCT197.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 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
Period 1 and Period 2
Period 1 - BCT197 14mg on Day 1
Period 2 - BCT 197 14mg on Day 1 and Azithromycin 500mg on Day 1,2 and 3
干预措施: BCT197 (Drug)
Period 1 and Period 2
Period 1 - BCT197 14mg on Day 1
Period 2 - BCT 197 14mg on Day 1 and Azithromycin 500mg on Day 1,2 and 3
干预措施: Azithromycin (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve (AUC) BCT197 in the presence and absence of Azithromycin.
时间窗: Pre-dose to Day 15
Period 1: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72,96, 144, 168 hours post BCT197 dose on Day 1. Period 2: Pre BCT197 dose, 1, 2, 4, 6, 12, 24, 36, 48,72, 96,144, 168 and 336 hours post BCT197 dose on Day 1.
Maximum Measurable Plasma Concentration (Cmax) BCT197 in the presence and absence of Azithromycin.
时间窗: Pre-dose to Day 15
Period 1: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72,96, 144, 168 hours post BCT197 dose on Day 1. Period 2: Pre BCT197 dose, 1, 2, 4, 6, 12, 24, 36, 48,72, 96,144, 168 and 336 hours post BCT197 dose on Day 1.
次要结局
- The number of adverse events during administration of BCT197 alone and in the presence of Azithromycin.(Day 1 to Day 22)