PHASE I STUDY OF SINGLE ORAL DOSE OF Se-METHYL-SELENO-L-CYSTEINE (MSC) IN ADULT MEN
I. To evaluate the toxicity of MSC, given to healthy adult males as a single oral dose.
I. To characterize the pharmacokinetics of single oral doses of MSC in healthy adult male
II. To evaluate the baseline selenium content of toenail clippings in healthy adult males.
OUTLINE: This is a multicenter, randomized, placebo controlled, double blind, dose
escalation study. Participants are randomized to 1 of 2 arms.
Arm I: Participants receive oral placebo on day 1.
Arm II: Participants receive oral Se-methyl-seleno-l-cysteine (MSC) on day 1. Cohorts of 5
participants receive escalating doses of MSC until the maximum tolerated dose (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.
Participants undergo blood, urine, and toenail clipping collection for pharmacokinetic and
correlative studies. Samples are analyzed for plasma protein levels of selenium for
proteomic and gene expression, molecular fingerprinting by mass spectrometry, and RNA by
gene array analysis.
After completion of study treatment, participants are followed at 7-14 days and at 30 days.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Clinical toxicity in healthy adult male volunteers, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v3.0
Summarized using descriptive statistics.
Up to 30 days
United States: Food and Drug Administration
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