A Phase I Healthy Volunteer Study Investigating the Safety, Tolerability & Pharmacokinetics of Co-administered Single Doses of OZ439 and Mefloquine
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- OZ439 AUC0-t
研究概览
简要总结
OZ439 is a novel, synthetic trioxolane medicine which is related to artemisinin, but has the advantage of a longer elimination half-life so is being developed to be administered together with a potential partner drug e.g. mefloquine as a single dose cure for uncomplicated malaria. The study findings will be used to inform the dose and design of future studies. The aim of the study is to establish the safety, tolerability and pharmacokinetics of co-administered OZ439 and MQ at a range of doses up to the maximum tolerated dose, in healthy volunteers.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and non-childbearing potential female volunteers of between 18 and 55 years of age
- •Female volunteers must have a negative serum pregnancy test at screening
- •Females must be of non-childbearing potential
- •Male volunteers and their partner(s) must agree to use a double barrier method of contraception for at least 14 days prior to first dose of study drug through 90 days after the last dose.
- •Body mass Index between 18 and 30kg/m2, inclusive; and a total body weight >50 kg
- •Laboratory tests at screening within normal ranges or not clinically significant as judged by the Investigator.
排除标准
- •Received an investigational drug or participated in another research study within 30 days of the first dose of study drug or at any time through the study
- •Evidence of current or history of clinically significant oncologic, pulmonary, hepatic, cardiovascular, gastrointestinal, haematologic, metabolic, neurological, immunologic, nephrologic, endocrine, psychiatric disease, or clinically significant current infection.
- •Any condition that could possibly affect drug absorption, such as gastrectomy, diarrhea and lactose intolerance
- •Use of any medications, vitamins, herbal supplements, dietary supplements or vaccinations within 14 days of the first dose of study drug or at any time through the study, unless prior approval is granted. This includes any drugs that are substrates, inhibitors or inducers of CYP3A
- •Intermittent use of acetaminophen at doses of up to 2g/day is permitted
- •History of drug or alcohol abuse within 2 years of Screening
- •History of alcohol consumption within 24 hours of any study visit
- •Tobacco users
- •Consumption of fruit juices within 7 days prior to dosing
- •Participation in unaccustomed strenuous exercise within 7 days prior to
- •Positive urine drug screen
- •Positive test for HIV-1, HBsAg or HCV
- •Known hypersensitivity to MQ or artemisinins
- •QTcF greater than 450msec
研究组 & 干预措施
OZ439 100mg single dose
OZ439 100mg single dose oral suspension
干预措施: OZ439 100mg (Drug)
OZ439 100mg plus MQ 250mg single doses
Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet
干预措施: OZ439 100mg (Drug)
OZ439 100mg plus MQ 250mg single doses
Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet
干预措施: MQ 250 mg, single dose (Drug)
OZ439 400mg single dose
OZ439 400mg single dose oral suspension
干预措施: OZ439 400mg (Drug)
OZ439 400mg plus MQ 750mg single doses
Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets
干预措施: OZ439 400mg (Drug)
OZ439 400mg plus MQ 750mg single doses
Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets
干预措施: MQ 750mg, single dose (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
OZ439 AUC0-t
时间窗: Up to 42 days post-dose
Area under the plasma concentration versus time curve (AUC) of OZ439
次要结局
- OZ439 Cmax(Up to 42 days post-dose)
- MQ AUC0-t(Up to 42 days post-dose)
- MQ Cmax(Up to 42 days post-dose)