NCT00292929已完成1 期
A Phase 1 Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Single Intravenous Doses of Artesunate Administered to Healthy Subjects
U.S. Army Medical Research and Development Command2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2006年2月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to establish the safety, tolerability and pharmacokinetics of a single dose of the antimalarial drug artesunate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
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 adult males and non-pregnant, non-lactating females
- •Have a normal ECG that may include benign PAC's and PVC's, 1st degree AV block, 2nd degree AV block, Wenckebach
- •Have a normal blood pressure (BP) and heart rate (HR). These will be measured after resting supine for about 3 minutes. Normal BP is defined as less than 140 mm Hg systolic and less than 90 mm Hg diastolic. Normal baseline HR is 50 to 90 bpm without symptoms.
- •Body mass index between 18 and 29 kg/m**2 or, if out of range, not clinically significant (within 15% of their ideal body weight).
- •Be able to verbalize understanding of the consent form, provide written informed consent and verbalize willingness to complete study procedures
- •Have a brief physical examination that demonstrates no clinically significant contraindication for participating in the study.
- •If female, have a negative serum pregnancy test at screening and urine pregnancy at admission or be postmenopausal, had a hysterectomy, been sterilized, or agrees to practice effective contraception for the duration fo the study and for a period of 12 weeks after stopping study drug.
排除标准
- •Have received any investigational drug or vaccine in the period 0 to 16 weeks before entry to the study.
- •Have been on a liquid protein diet in the last year
- •Have any clinically significant abnormal physical findings at the screening examination
- •Have any clinically significant abnormalities in the results of laboratory screening evaluation
- •Have used any prescription drugs within 14 days prior to admission or non-prescription drugs (including herbals or dietary supplements) within 7 days prior to admission
- •Existence of any surgical or medical condition that, in the judgement of the clinical investigator, might interfere with the distribution, metabolism or excretion of the drug
- •Presence of history of drug allergy requiring treatment. Hay fever is allowed unless it is active or has required treatment within the previous 2 months
- •Donation or loss of greater than 400 ml of blood in the period 0 to 12 weeks before entry to the study.
- •Serious adverse reaction or hypersensitivity to any drug, particularly artemisinins
- •CAGE (screening test for alcoholism) positive (2 out of 4 criteria) or has a history of recent alcohol abuse
- •Use of illicit drugs
- •Family history of sudden cardiac death or prolonged QT syndrome (defined as 500 msec noted in repeat tracings)
- •History of seizure, syncope, or trouble with hearing or balance or other neurological disorder
- •History of severe psychiatric disorder or hospitalization for severe psychiatric disorder
- •Current job or personal habit of reversed sleep-wake cycle
- •History of cardiac disease to include cardiomyopathy, valvular disease, arrhythmia, ischemia, or enlarged heart
- •Presence of hepatitis B surface antigen (Hbs-Ag), hepatitis C antibody (antiHCV) or HIV type 1 at screening
- •Pregnancy
研究者
研究点 (2)
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