NCT00489372

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

Phase I Study of Single Oral Dose of Se-Methyl-Seleno-L-Cysteine (MSC) in Adult Men

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy, no Evidence of Disease

Interventions

Type	Name	Description
DRUG	Se-methyl-seleno-L-cysteine	Given orally
OTHER	placebo	Given orally
OTHER	pharmacological study	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-03-01
• Completion: 2009-07-01
• First posted: 2007-06-21
• Last updated: 2014-11-14

Locations

2 sites across 1 country: United States