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.
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. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
36
Northwestern University
Chicago, Illinois, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
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.
Time frame: Up to 30 days
Characterization of the pharmacokinetics of MSC
Descriptive statistics calculated for each cohort, using established pharmacokinetic analysis methods.
Time frame: Up to 24 hours post-dose
Selenium levels in toenail samples
Summarized graphically.
Time frame: Up to 24 hours post-dose
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Correlative studies