Safety Tolerability & Pharmacokinetics of Co-administered Single Doses of OZ439 & Piperaquine to Healthy Subjects
A Phase I Study to Investigate the Safety, Tolerability & Pharmacokinetics of Co-administered Single Doses of OZ439 and Piperaquine to Healthy Subjects
研究概览
地位
条件
详细说明
Placebo-controlled, double-blind, five-cohort, 2-period (per cohort) dose-escalation study.
For each subject, the study included a screening evaluation (within 21 days of the 1st dose), dosing on 2 separate occasions (Period 1 and Period 2) and a follow-up visit (6 weeks following the final dose).
Within each cohort, subjects were randomised into two sequences to receive OZ439 in Period 1 and OZ439 plus piperaquine in Period 2 (sequence 1, 8 subjects) or OZ439-matching placebo in Period 1 and OZ439/piperaquine matching placebos in Period 2 (sequence 2, 4 subjects).
Safety and tolerability were evaluated: Physical examination, ECG assessments including a full baseline matched profile of ECG tracings, vital signs, laboratory evaluations, in particular liver function tests and adverse events.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Mendrisio、瑞士、CH 6850
- Cross Research S.A.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Healthy males & females, 18-55 years old
- BMI 18 to 30kg/m2; total body weight >50kg
- Healthy, determined by pre-study medical history, physical examination vital signs, 12 Lead ECG
- Females of non-childbearing potential.
- Males must agree to use a double barrier method of contraception
- Lab tests at screening within the reference ranges
Exclusion Criteria:
- Any condition that could affect drug absorption, e.g. gastrectomy, diarrhea
- Clinically relevant abnormalities in ECG
- Family history of sudden death or of congenital prolongation of QTc interval - History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia
- Electrolyte disturbances
- History of drug or alcohol abuse, tobacco users
- Participation in evaluation of any drug for 3 months before the study
- Administration of ANY systemic medication/herbal product within 14 days of first dose of study drug.
- unaccustomed strenuous exercise within 7 days of any study visit
- Alcohol consumption within 24 hours of any study visit
- Consumption of any fruit juice or food containing grapefruit within 7 days
- Positive test for HIV-1, HBsAg or HCV
- Positive urine drug screen at Screening or admission
- Severe allergies/multiple drug allergies
- Volunteers who have donated blood or experienced significant blood loss within 90 days of screening
- Hemoglobin below lower limit of the reference range
- Clinically relevant abnormal lab values indicative of physical illness
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较:安慰剂
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安慰剂
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实验性的:OZ439 100mg
100mg OZ439 single oral dose
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100mg OZ439 oral suspension single dose
其他名称:
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实验性的:OZ439 100 mg + PQP 160mg
100mg OZ439 single oral dose + 160mg Piperaquine single oral dose
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100mg OZ439 oral suspension single dose
其他名称:
160 mg Piperaquine tablet
其他名称:
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实验性的:OZ439 100 mg + PQP 480mg
100mg OZ439 single oral dose + 480mg Piperaquine single oral dose
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100mg OZ439 oral suspension single dose
其他名称:
480 mg Piperaquine tablet
其他名称:
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实验性的:OZ439 100 mg + PQP 1440mg
100mg OZ439 single oral dose + 1440mg Piperaquine single oral dose
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100mg OZ439 oral suspension single dose
其他名称:
1440 mg Piperaquine tablet
其他名称:
|
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实验性的:OZ439 300mg
300mg OZ439 single oral dose
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300mg OZ439 oral suspension single dose
其他名称:
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实验性的:OZ439 300 mg + PQP 1440mg
300mg OZ439 single oral dose + 1440mg Piperaquine single oral dose
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1440 mg Piperaquine tablet
其他名称:
300mg OZ439 oral suspension single dose
其他名称:
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实验性的:OZ439 800mg
800mg OZ439 single oral dose
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800mg OZ439 oral suspension single dose
其他名称:
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实验性的:OZ439 800 mg + PQP 1440mg
800mg OZ439 single oral dose + 1440mg Piperaquine single oral dose
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1440 mg Piperaquine tablet
其他名称:
800mg OZ439 oral suspension single dose
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
OZ439 Cmax
大体时间:Up to 168 hours post-dose
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OZ439 Maximum concentration level
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Up to 168 hours post-dose
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Piperaquine Cmax
大体时间:Up to 1008 hours post-dose (Day 43)
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Piperaquine Maximum concentration level
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Up to 1008 hours post-dose (Day 43)
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OZ439 AUC(0-168)
大体时间:Up to 168 hours post-dose
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Area under the plasma concentration versus time curve to 168 hours post-dose.
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Up to 168 hours post-dose
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OZ439 t1/2
大体时间:Up to 168 hours post-dose
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OZ439 Elimination half-life
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Up to 168 hours post-dose
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Piperaquine AUC(0-168)
大体时间:Up to 1008 hours post-dose (Day 43)
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Piperaquine area under the plasma concentration versus time curve to 168 hours post-dose
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Up to 1008 hours post-dose (Day 43)
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Piperaquine t1/2
大体时间:Up to 1008 hours post-dose (Day 43)
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Piperaquine Elimination half-life (t1/2).
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Up to 1008 hours post-dose (Day 43)
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合作者和调查者
调查人员
- 首席研究员:Milko M Radicioni, MD PhD、Cross Research S.A.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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