ACTRN12613000698774已完成1 期
An experimental study to characterize the effectiveness of griseofulvin against early plasmodium falciparum blood stage infection in healthy volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •1. Volunteers will be adults (males or non pregnant females), aged between 18 and 45 years who do not live alone (from Day 1 until at least the end of the antimalarial drug treatment).
- •2. Volunteers must have a BMI within the range 18–30 kg/m2 and must weigh more than 50kg in adults in which the proposed dose has already been used.
- •3. Volunteers must understand the procedures involved and agree to participate in the study by giving fully informed, written consent.
- •4. Be contactable and available for the duration of the trial and be available up to 2 weeks following end of study visit. (maximum of 8 weeks).
- •5. Volunteers must be non-smokers for at least three months prior to screening.
- •6. This study will only be conducted in healthy male volunteers (that do not plan father children in the next 6 months) and female volunteers of non-childbearing potential (i.e. those who have had a hysterectomy, bilateral oophorectomy or tubal ligation or who are post-menopausal). As a precautionary measure, pregnancy testing will be conducted at screening on all eligible females, at the baseline assessment prior inoculation, prior to dosing and at the end of the study.
- •7. Good peripheral venous access.
排除标准
- •1.History of malaria
- •2.Evidence of increased cardiovascular disease risk (defined as greater than 10%, 5 year risk) as determined by the method of Gaziano et al.,
- •3.History of splenectomy.
- •4.SLE (systemic lupus erythematosus)
- •5.Porphyria
- •6.Pregnant or breast feeding
- •7.Men who may father children in the next six months
- •8.History of a severe allergic reaction, anaphylaxis or convulsions following any vaccination or infusion.
- •9.Presence of current or suspected serious chronic diseases or psychiatric illness
- •10.Volunteers unwilling to defer blood donations to the ARCBS for 6 months.
- •11.Known pre-existing prolongation of the QT interval or clinically significant
- •electrocardiogram (ECG) abnormalities
- •12. Recent or current therapy with an antibiotic or drug with potential antimalarial activity (tetracycline, azthromycin, clindamycin, hydroxychloroquine etc.).
- •13. Known hypersensitivity to griseofulvin, Mefloquine, artemether or lumefantrine.
- •14. Concomitant use of any drug which is metabolised by the cytochrome enzyme CYP2D621. Use of corticosteroids, anti-inflammatory drugs, any immunomodulators or anticoagulants.
- •15.Presence of acute infectious disease or fever (e.g., sub-lingual temperature 38.5 degrees Celsius) within the five days prior to study product administration).
- •16.Evidence of acute illness within the four weeks before trial prior to screening.
- •17.Significant intercurrent disease of any type, in particular liver, renal, cardiac, pulmonary,
- •neurologic, rheumatologic, or autoimmune disease by history, physical examination, and/or
- •laboratory studies including urinalysis.
- •18.Participant has a clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion, e.g. gastrectomy, diarrhoea.
- •19.Alcohol consumption greater than community norms (i.e. more than 21 standard drinks per week for males and 14 standard drinks per week for females).
- •20.Currently consuming a low fat diet.
- •21.A history of drug habituation, or any prior intravenous usage of an illicit substance.
- •22.Participation in any research study involving significant blood sampling, or blood donation to Red Cross (or other) blood bank during the 8 weeks preceding the reference drug dose in the study.
- •23.Have ever received a blood transfusion.
- •24. Positive test for HIV, Hepatitis B, hepatitis C.
- •25. Any clinically significant biochemical or haematologic abnormality (Hb must be greater than or equal to 11.5g/dL for females; 13.0g/dL for males)– including red cell antibodies
- •26.Evidence of any condition that, in the opinion of the clinical investigator, might interfere with the evaluation of the study objectives or pose excessive risks to volunteers.
- •27.Any circumstances or conditions, which, in the opinion of the PI, may affect full participation in the trial or compliance with the protocol.
研究者
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