(NWU09-4-03) Phase I Multiple Dose Study of 12-Week Treatment by Se-Methyl-L-Cysteine(MSC) and L SeMet in Adult Males

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Title (NWU09-4-03) Phase I Multiple Dose Study of 12-Week Treatment by Se-Methyl-L-Cysteine(MSC) and L SeMet in Adult Males
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Principal Investigator Roberto Pili, MD
Study Number 182210
Phase1
Summary This is a dose finding study in healthy adult males within the age range which prostate cancer diagnosis is most common (50-80 years).  Participants will be randomized to one of 3 treatment groups receive selenium as methyl selenocysteine or selenomethionine or placebo.  The study treatment period will be for about 3 months.  Blood will be drawn several times for analysis on day 1 and the final day (84) of this study.  Researchers will analyze the blood to see how the body digests and process each of these forms of selenium.  Tolerability of the treatments will also be monitored closely.
Eligibility
  • Men age 40-80 years. 
  • Body weight 110-250 lbs. 
  • Adequate bone marrow, liver and kidney function per laboratory assessments. 
  • Life expectancy greater than 3 years. 
  • Agree to not take any selenium products other than those provided while on study. 
  • Willing to remain in clinic for 13 hours on days 1, final day (84) and return to clinic for required visits. 
  • Must not have any medical conditions that in the opinion of the treating physician would make this protocol dangerous for the participant.
For more information about the clinical study go to Clinicaltrial.Gov