Phase 1 Assessment of Safety and Pharmacokinetics of a Low Dose of Methotrexate in Healthy Adult Male Kenyan Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Clinical safety parameters:oral ulcers, GI tract disturbance,hematology, renal hepatic & other unsolicited safety AEs
研究概览
简要总结
Previous investigations indicate that methotrexate, an old anticancer drug, could be used at low doses to treat malaria. This is a phase I evaluation to assess the safety and pharmacokinetic profile of this drug in healthy adult male Kenyan volunteers.
详细描述
Background Currently the control of malaria rests on the use of chemotherapy. However, the development of resistance to common used drugs represents a major public concern. Thus, the investigators need to develop new and cheap drugs. The investigators have discovered that the old drug methotrexate (MTX), which is used in the treatment of cancer and rheumatoid arthritis (RA), is very active against malaria parasites, including those that are resistant to existing antimalarials.
In the treatment of RA, MTX is used weekly at a low dose for several years. At dose, MTX is safe and well tolerated in human and children. This low dose of MTX will also kill malaria parasite in human. Thus, want to study MTX as an antimalarial. As part of this study, the investigators need to establish whether at the dose the investigators want it, 5 mg per days for 5 days, the drug is safe and well tolerated in 25 Kenyan adult volunteers. This result of this study will inform us on the use of MTX in the treatment of malaria in children.
What questions are the investigators trying to answer?
The investigators are trying to assess the safety of 5mg dose per day for 5
Where is the study taking place, how many people does it involve and how are they selected?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males, Aged > 18 -< 55years old; weighing 55-75 kg
- •Serum haemoglobin >10g/dl
- •HIV negative status
- •Written informed consent from the study subject.
排除标准
- •Severe underlying conditions such as malnutrition (W/H <70%), clinically suspected cardiac, renal, or hepatic diseases, suspected AIDS, or severe injury.
- •Presence of any concomitant illnesses such malaria, lower respiratory tract infections (LRTI), acute bloody or non-bloody diarrhoeas, or other as acute infections
- •History of treatment with antimalarial drugs within the last 2 weeks
- •History of treatment with aspirin or any non-steroidal-anti-inflammatory agent or trimethoprim and co-trimoxazole within the last 7 days.
- •Any ongoing medication.
- •Abnormal clinical chemistry or haematological finding
- •Alcohol/drugs intake
- •Any other reason in the recruiting clinician's opinion that makes the individual unsuitable for taking part in a clinical trial.
研究组 & 干预措施
Methotrexate
Oral methotrexate 5mg once daily for 5 consecutive days
干预措施: Methotrexate (Drug)
结局指标
主要结局
Clinical safety parameters:oral ulcers, GI tract disturbance,hematology, renal hepatic & other unsolicited safety AEs
时间窗: 42 days
次要结局
- Pharmacokinetics of Methotrexate assessed by repeated measurement of blood concentrations(42 days)