A Single-centre, Open-label, Exploratory Study to Investigate the Pharmacokinetics of Ethionamide and Ethionamide Sulfoxide in Patients Established on Treatment for Tuberculosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- BioVersys AG
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To determine the AUC of ethionamide in participants with tuberculosis (TB) when ethionamide is dosed under programmatic conditions.
研究概览
简要总结
To determine the pharmacokinetics of ethionamide (Eto) and ethionamide-sulfoxide (Eto-SO) in participants with tuberculosis (TB) when Eto is dosed under programmatic conditions.
详细描述
A single-centre, open-label, exploratory pharmacokinetic study. This study is designed to collect blood samples from participants established on a TB treatment regimen which includes Eto. These samples will be analysed for concentrations of Eto and its metabolite Eto-SO.
The medication will not be provided by the study, participants will receive their standard of care medication from their local clinic. Participants will continue to take their total daily dose of Eto on study as prescribed by their primary caregiver, this will not change for their participation on study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Provide written, informed consent prior to all trial-related procedures.
- •Male or female, aged between 18 and 65 years, inclusive.
- •Receiving Eto as a component of a treatment regimen for tuberculosis for at least one month at the time of enrolment.
- •Ability and willingness of participant or legally authorized representative to provide informed consent.
排除标准
- •Evidence of clinically significant conditions or findings, other than TB, that might compromise safety of the participant or the interpretation of trial endpoints, per discretion of the Investigator.
- •Receiving prohibited concomitant medications (see Prior and Concomitant Medications)
- •Evidence of illicit substance use (cannabis, methamphetamines, opiates)
- •Pregnant or breastfeeding or planning to become pregnant during the study period.
- •Laboratory values: participants with the following laboratory values at screening
- •creatinine >1.5 times upper limit of normal [ULN];
- •haemoglobin <8.5 g/dL;
- •Alanine aminotransferase (ALT) ≥2.0 x ULN;
结局指标
主要结局
To determine the AUC of ethionamide in participants with tuberculosis (TB) when ethionamide is dosed under programmatic conditions.
时间窗: 2 days
area under the plasma drug concentration versus time (AUC0-24)
To determine the AUC of ethionamide-sulfoxide in participants with tuberculosis (TB) when ethionamide is dosed under programmatic conditions.
时间窗: 2 days
area under the plasma drug concentration versus time (AUC0-24)
To determine the Cmax of ethionamide in participants with tuberculosis (TB) when ethionamide is dosed under programmatic conditions.
时间窗: 2 days
maximum observed plasma drug concentration (Cmax)
To determine the Cmax of ethionamide-sulfoxide in participants with tuberculosis (TB) when ethionamide is dosed under programmatic conditions.
时间窗: 2 days
maximum observed plasma drug concentration (Cmax)
次要结局
未报告次要终点