PILOT: The Effects of Short Term Administration of a Novel Glutathione Precursor (FT061452), on Serum and Intracellular Glutathione Levels
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Intracellular Glutathione Level
研究概览
简要总结
Glutathione is a powerful protective substance found within every cell in the body. It has been shown that glutathione levels go down as a person gets older, which makes a person more likely to get heart disease, high blood sugar problems and different kind of cancers. N-Acetyl Cysteine is used as a dietary supplement. It has been reported to increase glutathione levels in the body. The diet supplement called ProImmune is also changed by the body into glutathione. Therefore, the purpose of this study is to find out the effect of ProImmune in healthy people. This study will also help to prove whether or not the ProImmune is able to improve the blood levels of glutathione in healthy people.
详细描述
Glutathione (gamma-glutamyl-cysteine-glycine; GSH) is a powerful antioxidant found within every cell. GSH is predominantly known to protect the cells from damage caused by free radicals. The concentration of glutathione declines with age, stress, and in some age-related diseases. When glutathione becomes deficient, a series of events are initiated termed "oxidative stress" and the associated cell signaling leads to impaired immune function and similar abnormalities in numerous cell systems.
Oral glutathione is ineffective in replenishing glutathione levels and reversing the abnormal signaling pathways associated with oxidative stress. Intravenous glutathione has been shown to be effective but is short-lived. N-Acetyl Cysteine, a glutathione precursor, has had limited efficacy in clinical settings and suffers from an adverse effect profile.Null Hypothesis (primary): The administration of FT061452 will not increase serum and intracellular glutathione levels in comparison to N-Acetyl Cysteine (NAC), and placebo.
Null Hypothesis (secondary): The administration of FT061452 will not improve vascular function in comparison to N-Acetyl Cysteine (NAC), and placebo.
The Specific Aims of this pilot study are to:
- Compare the change in serum and intracellular glutathione levels following the administration of a novel oral glutathione precursor, FT061452, (modified glutathione with selenium added, and cystine replacing cysteine, in doses equivalent to NAC) compared to low dose or usual dose of NAC, and placebo.
- Compare the change in select clinical parameters (vascular function) following the administration of a novel oral glutathione precursor, FT061452, (modified glutathione with selenium added, and cystine replacing cysteine) compared to N-Acetyl Cysteine (NAC), and placebo.
- As a pilot study a third goal is to generate effect sizes for appropriately powering future clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will be healthy male or female, 30 to 65 years of age.
- •Subjects must have a BMI between 20 and
- •Subjects must be able to provide informed consent after risks and benefits have been explained.
- •Subjects must be non-smoking (defined as a subject who has not smoked for ≥ 6 months), and must agree to abstain from caffeine 72 hours prior to study day.
- •Subjects are in generally good health, based on pre-study medical history, physical examination and routine laboratory tests.
- •Subjects have, in the Investigator's opinion, no clinically significant disease and/or clinically significant abnormal laboratory values as determined by the Investigator based on medical history, physical examination, or laboratory evaluations conducted at the screening visit or on admission to the clinic.
排除标准
- •Subjects who have a history of drug or alcohol abuse within 6 months of study screening, as determined by the Investigator.
- •Subjects who have participated in any investigational trial within 30 days or six half-lives of the test drug's biologic activity, whichever is longer, before the start of the study (time of first dose).
- •Subjects who have clinically significant medical or psychiatric illnesses currently or within 30 days of start of study (time of first dose), as determined by
- •the Investigator.
- •Subjects who have had symptoms of any significant acute illness within 30 days prior to the start of study (time of first dose),
- •Subjects who have any condition that interferes with their ability to understand or comply with the requirements of the study.
- •Females who are pregnant or nursing or have a high likelihood of becoming pregnant during the study.
研究组 & 干预措施
Placebo low dose
Placebo for low dose group given as a single dose.
干预措施: Placebo low dose (Drug)
N Acetyl cysteine, 600mg (low dose)
N-Acetyl Cysteine (NAC)600 mg (low dose) given as a single dose.
干预措施: N Acetyl cysteine, 600mg (low dose) (Drug)
Proimmune 200(FT061452)
Proimmune 200(FT061452) low dose group 3000 mg given as a single dose.
干预措施: Proimmune 200 (FT061452) 3000mg low dose (Drug)
Placebo high dose
Placebo given to high dose group given as a single dose.
干预措施: Placebo (high dose) (Drug)
N Acetyly cysteine, 1200mg (high dose)
N-Acetyl Cysteine(NAC)1200mg (high dose) given as a single dose.
干预措施: N Acetyl cysteine, 1200mg (high dose) (Drug)
FT061452, 6000mg high dose
Proimmune 200(FT061452) high dose group given 6000 mg as a single dose.
干预措施: FT061452, 6000mg high dose (Drug)
结局指标
主要结局
Intracellular Glutathione Level
时间窗: 6 hours
Mean intracellular glutathione level every 2 hour
次要结局
- Augmentation Index(Baseline and 6 hours)
研究者
Naureen Tareen
Principal Investigator
Charles Drew University of Medicine and Science