Phase I Multiple Dose Study of 12-Week Treatment by Se-Methyl-L-Cysteine (MSC) and L SeMet in Adult Males
I. To determine the individual toxicity profiles of Se-methyl-seleno-L-cysteine (methyl
selenocysteine; MSC) and selenomethionine (SeMet) administered to cohorts of men daily for
twelve weeks, with dose escalation with each successive cohort.
I. To measure the pharmacokinetics of selenium, according to form (MSC vs SeMet): MSC and
SeMet impacts on plasma, albumin, and urinary concentrations of selenium over 48 hours on
dosing days 1 and 84.
II. To evaluate the pharmacodynamics of selenium by form (MSC vs SeMet): plasma, albumin,
and urinary Selenoprotein P (Sepp1) concentrations and glutathione peroxidase (GPx) activity
over 48 hours on dosing days 1 and 84.
III. To store plasma and formed elements (red cells plus platelets) for future analysis of
methyl selenol and other key selenium species, when those assays become available.
OUTLINE: This is a dose-escalation study. Participants are randomized to 1 of 3 treatment
ARM I: Participants receive Se-methyl-seleno-L-cysteine, selenomethionine, or placebo at the
first dose level orally (PO) on days 1-84.
ARM II: Participants receive Se-methyl-seleno-L-cysteine, selenomethionine, or placebo at
the second dose level PO on days 1-84.
ARM III: Participants receive Se-methyl-seleno-L-cysteine, selenomethionine, or placebo at
the third dose level PO on days 1-84.
Participants undergo plasma and urine sample collection periodically for pharmacokinetic and
pharmacodynamic studies. Samples are also stored for future proteomic and gene expression
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Clinical toxicity in healthy adult male volunteers according to the NCI CTCAE version 4.0
Up to 112 days
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|Vanderbilt University Medical Center||Nashville, Tennessee 37232-2516|
|Northwestern University||Chicago, Illinois 60611|