Phase 1b Clinical Trial Using Argemone Mexicana in Healthy Adults Infected or Not Infected With Plasmodium Falciparum in Mali: Pharmacokinetics and Observational Study
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of Adverse Events
研究概览
简要总结
The main objective is to study the pharmacokinetics, pharmacodynamics and tolerability of the decoction of the aerial parts of Argemone mexicana (AM), administered in healthy volunteers.
详细描述
This is an open non comparative safety and pharmacokinetic (PK) study clinical trial. Healthy volunteers aged from 18 to 50 years old will be recruited and followed 42 days after treatment initiation as in the current World Health Organization malaria drug protocol efficacy assessment protocol.
Each volunteer will be take oral Argemone mexicana in decoction formulation. For the PK assessment purposes, 3 groups have been constituted: (i) a group will receive a unique dose of with blood withdrawal scheduled at 0 hour, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hour , 8 hours and 12 hours. (ii) a group will receive two doses (morning and evening) of Argemone mexicana for 14 days with blood withdrawal scheduled at 0 hours, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 3 days, 7 days and 14 days. (iii) a group will receive two doses (morning and evening) of Argemone mexicana for 14 days with blood withdrawal scheduled at 0 hour, 12 hours, 14 hours, 16 hours, 18 hours, 20 hours, 22 hours, 24 hours, 3 days, 7 days, 14 days and 21 days Safety will be assessed clinically (Clinical exam and Electrocardiography) and biologically (hematology and biochemistry parameters will be measured) throughout the 42 days of thefollow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age of 18-50 years old;
- •be in good general health;
- •be available for the duration of the study;
- •agreement to participate in the study
- •be a resident of the village known study;
- •acceptance of the conservation laboratory specimens for future research.
排除标准
- •Plasmodium falciparum infection with clinical manifestations;
- •Presence of severe or complicated malaria;
- •Acute medical condition;
- •Any other medical condition that requires medical attention inconsistent with the study or interfere with the study;
- •Severe medical conditions;
- •Allergy to the product of the study,
- •Pregnant women or nursing
- •Taking a derivative product of the study or other known antimalarial within 14 days before enrollment.
- •Refusal to participate
研究组 & 干预措施
Argemone mexicana
Argemone mexicana is traditional medicinal plant known as having an antimalarial activity.
The aerial part of this plant is used. The decoction of the powder of the plant will be used.
干预措施: Argemone mexicana (Drug)
结局指标
主要结局
Number of Adverse Events
时间窗: 6 weeks
health volunteers will be assessed daily for 3 days and then on Day 7 and then weekly up to 6 weeks.
次要结局
- Plasma concentration curves of the drug(6 weeks)
研究者
Issaka Sagara, M.D., MSPH
Principal Investigator
University of Bamako