Evaluating Pharmacokinetics and Whole Blood Bactericidal Activity Against Mycobacterium Tuberculosis of Single 'High' Doses of Rifampicin in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Cumulative WBA (reported as change in Mtb log CFU per day)
研究概览
简要总结
The purpose of this study is to evaluate the bactericidal activity against Mycobacterium tuberculosis of standard and high doses of rifampicin. Pharmacokinetics (PK) and Whole blood Bactericidal Activity (WBA) will be measured in healthy volunteers following a single dose of rifampicin at standard dose (10mg/kg) or at high dose (20mg/kg or 30mg/kg).
详细描述
WBA is an ex vivo model for measuring the combined effects of administered drugs, host factors and strain factors on mycobacterial killing. If performed in parallel with PK measurements, the method can be used to evaluate the effect of drugs throughout the dosing cycle. This study aims to compare different doses of rifampicin in the WBA model, compare activity of rifampicin on WBA by different mycobacterium tuberculosis strain types and assess the host immune response following drug administration.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 21 and above
- •Male or female willing to comply with the study visits and procedures
- •Willing and able to provide written informed consent
排除标准
- •Women who are currently pregnant or breastfeeding
- •Signs of active TB
- •On immunosuppressant, antibiotic or any medication known to have interaction with rifampicin
- •Previous allergy to Rifampicin
- •Evidence of renal or hepatic dysfunction or any clinically significant deviation from normal during screening including laboratory determinations
- •Known hepatic disease or alcohol abuse
- •Current use of any other drugs, over the counter medications and herbal preparations that are known or potential inhibitors or inducers of cytochrome P450 enzymes
- •Any other significant condition that would, in the opinion of the investigator, compromise the volunteer's safety or outcome in the trial
- •Current participation in other clinical intervention trial or research protocol
研究组 & 干预措施
Group 1
10mg/kg Rifampicin
干预措施: Rifampicin (Drug)
Group 2
20mg/kg Rifampicin
干预措施: Rifampicin (Drug)
Group 3
30mg/kg Rifampicin
干预措施: Rifampicin (Drug)
结局指标
主要结局
Cumulative WBA (reported as change in Mtb log CFU per day)
时间窗: 24 hours
次要结局
- The pharmacokinetic profile of rifampicin(24 hours)