A Study to Determine the Range of Tissue Frataxin Concentrations and Other Potential Biomarkers for Friedreich's Ataxia in Normal Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Examine tissue frataxin concentrations in buccal cells, blood and skin cells
研究概览
简要总结
To examine range of tissue frataxin (FXN) concentrations, specific ribonucleic acids, other proteins and specialized lipids in the buccal cells, blood, and skin cells of normal healthy volunteers without Friedreich's ataxia (FRDA).
详细描述
Primary Objective: To examine the range of tissue frataxin (FXN) concentrations in the buccal cells, blood, and skin cells of normal healthy volunteers without FRDA.
Secondary Objective: To examine the range of specific ribonucleic acids (RNAs), other proteins, and specialized lipids in the buccal cells, blood, and skin cells of normal healthy volunteers without FRDA.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is a healthy male or female,18-50 years of age
- •Subject has a body mass index (BMI) ≥18.0 and ≤32.0 as of the screening visit.
- •Subject is racially Caucasian, Asian, Native Hawaiian, or Native American.
排除标准
- •Subject used erythropoietin, etravirine, or gamma interferon within 3 months prior to the Day 1 (assessment) visit.
- •Subject has a chronic condition that requires ongoing prescription drug treatment.
- •Subject use of any statin medications within 3 months before the Day 1 (assessment) visit.
- •Subject use of any lipid-lowering agents, other than statins, within 6 weeks before the Day 1 (assessments) visit.
- •Subject is racially black or African American.
- •Pregnant or breast-feeding female subjects.
- •Subject has a known history of drug or alcohol abuse or current suspected drug or alcohol abuse.
- •Subject is positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg), or hepatitis A virus (HAV).
- •Subject has any condition, disease, or situation, that in the opinion of the principal investigator (PI), could confound the results of the study or put the subject at undue risk, making participation inadvisable.
结局指标
主要结局
Examine tissue frataxin concentrations in buccal cells, blood and skin cells
时间窗: 1 day
Range of tissue frataxin levels in buccal cells, blood and skin cells
次要结局
- Examine specific ribonucleic acids (RNAs), other proteins, and specialized lipids in buccal cells and blood(1 day)