An Open-label, 2-period, Single-sequence, Crossover Study to Evaluate the Effect of Multiple Oral Dosing of Itraconazole on BCT197 Systemic Exposure in Healthy Male Participants
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
- Maximum Measurable Plasma Concentration (Cmax) BCT197 in the presence and absence of itraconazole.
研究概览
简要总结
An Open-label, 2-period, Single-sequence, Crossover Study to Evaluate the Effect of Multiple Oral Dosing of Itraconazole on BCT197 Systemic Exposure in Healthy Male Participants.
详细描述
This will be an open label study conducted in healthy male participants at a single centre. Each participant will participate in a screening visit and 2 study periods. At the first study period, all participants will receive a single dose of BCT197 and at study period 2, all participants will receive 14 daily doses of itraconazole 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
- •Healthy male participants.
- •Non-smokers (including e-cigarettes).
- •Body mass index (BMI) ≥ 18 and ≤ 30 kg/m
- •Willing to use highly effective barrier contraception methods.
- •Male participants must not donate sperm during the study.
排除标准
- •Any participants with pre-existing active skin disease.
- •Laboratory values at screening which are deemed to be clinically significant.
- •Participants with abnormal liver function tests.
- •12 Lead ECG with QTcF >450 msec.
- •Allergy to any of BCT197 excipients.
- •Known hypersensitivity or intolerance to itraconazole.
- •Taking medications known to cause QTc prolongation.
- •Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
- •Any clinically significant illness within 30 days prior to study drug administration.
- •Participants who, in the opinion of the Investigator, are unsuitable for participation in the study.
研究组 & 干预措施
Period 1 and Period 2
Period 1 - BCT197 14mg on Day 1
Period 2 - itraconazole 200mg on Day 1 to 14 and BCT197 14mg on Day 7
干预措施: BCT197 (Drug)
Period 1 and Period 2
Period 1 - BCT197 14mg on Day 1
Period 2 - itraconazole 200mg on Day 1 to 14 and BCT197 14mg on Day 7
干预措施: Itraconazole 200 mg (Drug)
结局指标
主要结局
Maximum Measurable Plasma Concentration (Cmax) BCT197 in the presence and absence of itraconazole.
时间窗: Pre-dose to Day 15
Period 1: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144 and 168 hours post BCT197 dose on Day 1. Period 2: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144, 168 and 192 hours post BCT197 dose on Day 7.
Area under the plasma concentration-time curve (AUC) BCT197 in the presence and absence of itraconazole.
时间窗: Pre-dose to Day 15
Period 1: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144 and 168 hours post BCT197 dose on Day 1. Period 2: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144, 168 and 192 hours post BCT197 dose on Day 7.
次要结局
- The number of adverse events during administration of BCT197 alone and in the presence of itraconazole.(Day 1 to Day 21)