Phase I Study of Oxfendazole (Toward the Treatment of Neurocysticercosis)
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- serious adverse events
研究概览
简要总结
This research is being done to learn about the safety in humans of a medicine that is already used in cows and pigs to treat worms. The medicine may be useful for people who have these or other worms. The medicine will be studied first in healthy people, who will be given a very small amount of the medicine once. If the smallest amount of medicine is found to be safe, a slightly higher amount will be given to a new group of volunteers. The highest amount that will be tested is similar to the amount given to animals. If the medicine can be given safely to healthy people in the planned amounts, a later study will be done in people who have worms to see if the medicine kills the worms.
详细描述
The Phase I study proposed is a randomized, double-blind, placebo-controlled evaluation of the safety and pharmacokinetics of escalating single oral doses of oxfendazole (0.3 to 30 mg/kg) in healthy volunteers. The dose will be increased approximately three-fold (one-half log) at each increment, and each cohort will comprise ten volunteers (eight drug, two placebo). Subjects will be monitored for three weeks after dosing, including monitoring the pharmacokinetics and metabolism of oxfendazole in blood and urine. Each new cohort will be dosed only after the three week safety data for the preceding group have been analyzed. If a clinically significant adverse event is observed, and if this event is possibly drug-related, an additional (and final) cohort of volunteers will repeat the highest tolerated dose of oxfendazole. Up to 70 volunteers (56 drug, 14 placebo) will complete the study.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Height and weight within 25% of means for his/her gender and age.
- •Willing to use two acceptable methods of contraception (approved oral, injectable, or implantable drug, IUD, diaphragm or condom with spermicidal jelly or foam, or sexual abstinence) for a minimum of one week before, and three weeks after dosing with oxfendazole; or surgically sterile.
- •Able to give written informed consent.
- •Able to provide a home phone number, and the name, address, and phone number of a person willing to assist making contact during the follow-up phase of the study.
排除标准
- •Pregnant.
- •Breast feeding.
- •Chronic drug/alcohol user.
- •Has clinically significant abnormalities in screening examinations
- •Has history of sensitivity to related benzimidazole compounds (e.g. albendazole, mebendazole).
研究组 & 干预措施
oxfendazole 0.3
administration of a single oral 0.3mg/kg dose of oxfendazole
干预措施: oxfendazole (Drug)
placebo comparator
administration of a single oral dose of placebo
干预措施: placebo (Drug)
oxfendazole 1.0
administration of a single oral 1.0 mg/kg dose of oxfendazole
干预措施: oxfendazole (Drug)
oxfendazole 3.0
administration of a single oral 3 mg/kg dose of oxfendazole
干预措施: oxfendazole (Drug)
oxfendazole 10
administration of a single oral 10 mg/kg dose of oxfendazole
干预措施: oxfendazole (Drug)
oxfendazole 20
administration of a single oral 20 mg/kg dose of oxfendazole
干预措施: oxfendazole (Drug)
oxfendazole 30
administration of a single oral 30 mg/kg dose of oxfendazole
干预措施: oxfendazole (Drug)
结局指标
主要结局
serious adverse events
时间窗: up to three weeks after dosing
Proportion of patients who present with serious adverse events (SAEs) related to oxfendazole.
次要结局
- adverse events(up to three weeks after dosing)
- Pharmacokinetic Profile(blood samples are drawn at 17 time points up to three weeks and urine is collected at 7 intervals up to 72 hours after dosing)
研究者
Robert Gilman
Professor
Johns Hopkins Bloomberg School of Public Health