Mitochondrial Targeted Biofuels as Countermeasures Against Chemical Threats
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- Attenuation by the succinate prodrug of toxin-induced decrease in mitochondrial respiration.
研究概览
简要总结
The purpose of the study is to determine in vitro effects on mitochondrial function of selected chemical agents in human cells, and assess the capability of a cell-permeable succinate prodrug to attenuate toxic effects The project aims at repurposing this recent pharmaceutical discovery, currently being developed for treatment of toxic exposure, for an expanded indication to treat chemically induced mitochondrial toxicity.
详细描述
The study duration per subject will be approximately 15 minutes to complete the one time blood collection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females age greater or equal 2 years of age
- •Weight greater or equal to 10 kg
- •Parental/guardian permission (informed consent) and if appropriate, child assent.
排除标准
- •Known primary mitochondrial disorder.
- •Use of an investigational drug within 30 days prior to enrollment.
- •Parents/guardians or subjects who in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- •Volunteer Inclusion Criteria
- •Males or females > 18 years of age
- •Employee, trainee, or student informed consent
- •Volunteer Exclusion Criteria:
- •Prior enrollment in this study.
- •Known primary mitochondrial disorder.
- •Use of an investigational drug within 30 days prior to enrollment.
结局指标
主要结局
Attenuation by the succinate prodrug of toxin-induced decrease in mitochondrial respiration.
时间窗: by end of 2018
Data will be assessed using 2-tailed Student's t-test. Dose-response curves for respiration will be made for each toxin and IC50 calculated. In case of difficulties in demonstrating acute toxicity of chemical agents, dose-titration experiments and long-term incubation (up to 24 hours) will be performed
次要结局
- Attenuation of toxin-induced decrease in mitochondrial membrane potential and attenuate lactate production by the succinate prodrug.(by end of 2018)