Efficacy, Safety and Pharmacokinetics of Ascending Dosages of Emodepside and in Comparison to Ivermectin Against Strongyloidiasis Stercoralis in Adults: Randomized Stage II Seamless Adaptive Controlled Trials
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Cure rate (CR) of emodepside against Strongyloides stercoralis
研究概览
简要总结
Efficacy, safety and pharmacokinetics of ascending dosages of emodepside and in comparison to ivermectin against Strongyloidiasis stercoralis in adults: randomized stage II seamless adaptive controlled trials
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent signed by the participant him/herself
- •Males and females of age 18 or older
- •Infected with S. stercoralis (positive by at least two Baermann assays on two different days and infection intensities of at least 0.75 LPG in the two stool samples.
- •Agree to comply with the study procedures, including to be examined by a study physician at the beginning of the study and to provide three stool samples during the screening period (within a maximum of 10 days) and approximately three weeks after treatment (follow-up).
- •Female participants of childbearing potential to ensure adequate contraception during the study period.
排除标准
- •No written informed consent by individual.
- •Presence of acute or uncontrolled systemic illnesses (e.g. severe anemia, clinical malaria) as assessed by a medical doctor, upon initial clinical assessment.
- •Recent history of acute or severe chronic disease, as assessed by a medical doctor or reported by the participant: Type 1 and/or 2 diabetes; Psychiatric disorders; Chronic heart, liver, or renal disease
- •Prior treatment with anthelmintics (eg, diethylcarbamazine [DEC], suramin, ivermectin, mebendazole or albendazole) within 4 weeks before planned study drug administration.
- •Actively participating in other clinical trials during the study.
- •Positive pregnancy test or breastfeeding women and planning to become pregnant within three months of study drug administration.
- •Received strong CYP3A4 inducers or inhibitors as well as concomitant treatments that are relevant substrate for CYP3A4 such as clarithromycin, erythromycin and rifampicin within 4 weeks before planned study drug administration.
- •Received strong P-gp inhibitors as well as concomitant treatments that are relevant substrates for P-gp such as clotrimazole and ritonavir.
- •Known allergy to study drugs or any of the ingredients
研究组 & 干预措施
Emodepside 5 mg
Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.
干预措施: Emodepside (Drug)
Emodepside 10 mg
Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.
干预措施: Emodepside (Drug)
Emodepside 15 mg
Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.
干预措施: Emodepside (Drug)
Emodepside 20 mg
Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.
干预措施: Emodepside (Drug)
Emodepside 25 mg
Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.
干预措施: Emodepside (Drug)
Emodepside 30 mg
Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.
干预措施: Emodepside (Drug)
Placebo
Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.
干预措施: Emodepside (Drug)
Ivermectin 3 mg
Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo.
干预措施: Emodepside (Drug)
结局指标
主要结局
Cure rate (CR) of emodepside against Strongyloides stercoralis
时间窗: In the week between 14 and 21 days post-treatment
The CR will be calculated as the proportion of Strongyloides stercoralis larvae-positive participants at baseline who become larvae-negative after treatment.
次要结局
- Cure rate (CR) and egg reduction rate (ERR) with other soil-transmitted helminths (STH) and trematodes(In the week between 14 and 21 days post-treatment)
- Geometric Mean Larvae Reduction Rate (LRR) of emodepside against Strongyloides stercoralis.(In the week between 14 and 21 days post-treatment)
- Safety and tolerability of the dose-dependent emodepside treatment regimes, and compared with ivermectin.(Actively evaluated at 3 hours, 24 hours, 72 hours, and 14 days post-treatment)
- Exposure response of emodepside in adults(Actively collected at 0 hours, 0.5 hours, 2.5 hours, 5 hours, 24 hours, 72 hours, and 14 days post-treatment)