NCT00563914已完成1 期
An Open Label, 4 Escalating Dose, Randomized Multicentre Study Evaluating the Safety and Activity of Ferroquine Associated With Artesunate Versus a Positive Calibrator (Amodiaquine Associated With Artesunate) in African Adult Patients With Uncomplicated Malaria
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Hepatic safety :ALT, AST, Alkaline Phosphatase, Total Bilirubin
研究概览
简要总结
The primary objective is to assess the safety of different doses of ferroquine with artesunate (AS) in adult African patients with uncomplicated malaria.
The secondary objectives are to assess activity in reducing parasitemia and the pharmacokinetics of ferroquine and its metabolites.
详细描述
The study duration is 30 days including a 2 day screening period, a 3 day treatment period with a follow-up period of 25 days. Patients remain hospitalized 4 days.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Body weight between 50 kg and 90 kg with Body Mass Index >18 kg/m²
- •Presence of body temperature ≥ 37.5°C or history of fever within the last 24 hours
- •Monoinfection with Plasmodium falciparum and parasitemia within the 100 to 200,000/microL
排除标准
- •Hypersensitivity to quinoleines or artesunate
- •History or presence of any clinically significant disease or symptoms which, in the judgment of the investigator, might confuse the interpretation of the safety and efficacy information
- •Splenectomized patients
- •Laboratory parameters outside normal ranges
- •Presence of HBs antigen, anti-HCV antibodies and anti-HIV 1&2 antibodies
- •Cardio vascular and Electrocardiogram parameters outside normal values
- •Presence of criteria of complicated malaria
- •Permanent vomiting
- •Previous treatment within 5 times the elimination half-life of any anti-malaria agents or with any marketed or investigational drugs (including St John's Wort) within 14 days before administration, or within 5 times the elimination half-life of that drug, whichever the longest, especially CYP3A and 2D6 main substrates
- •Positive results on urine drug screen for anti-malaria agents (aminoquinolines)
- •History of drug or alcohol abuse (alcohol consumption > 40 grams/day ; i. e. 2.5 beers of 33cl with 5 degrees of alcohol)
- •Intention to use herbal medicine during the study period
- •Immunization injection within last 15 days
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
干预措施: ferroquine (SSR97193) (Drug)
2
Active Comparator
干预措施: amodiaquine (Drug)
结局指标
主要结局
Hepatic safety :ALT, AST, Alkaline Phosphatase, Total Bilirubin
时间窗: Sreening , baseline, days D3,D5,D6,D7,D9,D14,D21 and D28
次要结局
- Parasite clearance assessed by repeated measurements of parasitemia(Sreening, days D1(T6 and T12),D2 (T0 and T6), D3( T0, T6 and T12) ,D4,D7,D14,D21and D28)
- Pharmacokinetics of ferroquine assessed by repeated measurement of blood concentration(up to 28 days after last dosing)
研究者
研究点 (1)
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