Phase I Study of Single Oral Dose of Se-Methyl-Seleno-L-Cysteine (MSC) in Adult Men
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Clinical toxicity in healthy adult male volunteers, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v3.0
研究概览
简要总结
This randomized phase I trial is studying the side effects and best dose of Se-methyl-seleno-L-cysteine in healthy adult men. Studying samples of blood, urine, and toenail clippings in the laboratory from healthy men receiving Se-methyl-seleno-L-cysteine may help doctors learn more about how Se-methyl-seleno-L-cysteine works in the body.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the toxicity of MSC, given to healthy adult males as a single oral dose.
SECONDARY OBJECTIVES:
I. To characterize the pharmacokinetics of single oral doses of MSC in healthy adult male volunteers.
II. To evaluate the baseline selenium content of toenail clippings in healthy adult males.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Total body weight between 50 and 115 kg
- •Hgb > 12 gm/dl
- •Platelets > 100,000/μL
- •ANC > 1000/μL
- •Creatinine < 1.5 mg/dl
- •SGPT and SGOT < 3 X the institutional upper limit of normal (ULN)
- •Total bilirubin < 1.5 X the institutional ULN (subjects with a higher level of bilirubin due to a familial metabolism will be considered on an individual basis)
- •Life expectancy greater than 2 years
- •Male subjects must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and until study completion (i.e., at least two weeks after dose of study drug)
- •Ability to understand and the willingness to sign a written informed consent document
- •Agree to refrain from use of selenium supplements while on study
排除标准
- •Not willing to remain at RPCI, and in follow up, as required
- •Presence of medical conditions, which in the opinion of the investigators, would compromise either the subject, or the integrity of the data
- •Individuals with a history of active liver or kidney disease within the past 6 months
- •Treatment with an investigational drug within 30 days prior to the dose of study drug
- •Use of prescription or nonprescription drugs, vitamins, or herbal supplements known to change gastric acidity (e.g., H2-antagonists, proton pump inhibitors, antacids) within 3 days of study drug administration
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to MSC (e.g. reaction to other selenium supplements)
- •Subjects who have donated 1 unit of blood within 30 days prior to the first dose of MSC
- •Subjects with a known history of heavy metal exposure, such as lead, mercury, of arsenic
- •ECOG performance status > 1
- •AUA total symptom score > 10 (or any individual symptom score of greater than or equal to 4 will exclude the participant)
研究组 & 干预措施
Arm I (placebo)
Participants receive oral placebo on day 1.
干预措施: placebo (Other)
Arm I (placebo)
Participants receive oral placebo on day 1.
干预措施: pharmacological study (Other)
Arm I (placebo)
Participants receive oral placebo on day 1.
干预措施: laboratory biomarker analysis (Other)
Arm II (Se-methyl-seleno-L-cysteine)
Participants receive oral Se-methyl-seleno-l-cysteine (MSC) on day 1. Cohorts of 5 participants receive escalating doses of MSC until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 5 or 2 of 10 patients experience dose-limiting toxicity.
干预措施: Se-methyl-seleno-L-cysteine (Drug)
Arm II (Se-methyl-seleno-L-cysteine)
Participants receive oral Se-methyl-seleno-l-cysteine (MSC) on day 1. Cohorts of 5 participants receive escalating doses of MSC until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 5 or 2 of 10 patients experience dose-limiting toxicity.
干预措施: pharmacological study (Other)
Arm II (Se-methyl-seleno-L-cysteine)
Participants receive oral Se-methyl-seleno-l-cysteine (MSC) on day 1. Cohorts of 5 participants receive escalating doses of MSC until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 5 or 2 of 10 patients experience dose-limiting toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Clinical toxicity in healthy adult male volunteers, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v3.0
时间窗: Up to 30 days
Summarized using descriptive statistics.
次要结局
- Characterization of the pharmacokinetics of MSC(Up to 24 hours post-dose)
- Selenium levels in toenail samples(Up to 24 hours post-dose)