Se-Methyl-Seleno-L- Cysteine (MSC) in Treating Healthy Patients

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy, no Evidence of Disease

In brief

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.

Key facts

Study ID

NCT00489372

Run by

National Cancer Institute (NCI)

People needed

36

Starts

2007-07-01

Expected to finish

2009-07-01

Last updated by the study team

2014-11-14

Who can join

Age: 18 and older, up to 70. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Northwestern University — Chicago, Illinois, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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