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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00489372
First received: June 20, 2007
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy, no Evidence of Disease
 Dietary Supplement: Se-methyl-seleno-L-cysteine
Other: placebo
Other: pharmacological study
Other: laboratory biomarker analysis
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: PHASE I STUDY OF SINGLE ORAL DOSE OF Se-METHYL-SELENO-L-CYSTEINE (MSC) IN ADULT MEN

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Clinical toxicity in healthy adult male volunteers, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v3.0 [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]
    Summarized using descriptive statistics.


Secondary Outcome Measures:
  • Characterization of the pharmacokinetics of MSC [ Time Frame: Up to 24 hours post-dose ] [ Designated as safety issue: No ]
    Descriptive statistics calculated for each cohort, using established pharmacokinetic analysis methods.

  • Selenium levels in toenail samples [ Time Frame: Up to 24 hours post-dose ] [ Designated as safety issue: No ]
    Summarized graphically.


Estimated Enrollment: 36
Study Start Date: July 2007
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm I (placebo)
Participants receive oral placebo on day 1.
 Other: placebo
Given orally
Other Name: PLCB
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm II (Se-methyl-seleno-L-cysteine)
Participants receive oral Se-methyl-seleno-l-cysteine (MSC) on day 1. Cohorts of 5 participants receive escalating doses of MSC until the 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.
 Dietary Supplement: Se-methyl-seleno-L-cysteine
Given orally
Other Names:
  • methylselenocysteine
  • MSC
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Total body weight between 50 and 115 kg
  • Hgb > 12 gm/dl
  • Platelets > 100,000/μL
  • ANC > 1000/μL
  • Creatinine < 1.5 mg/dl
  • SGPT and SGOT < 3 X the institutional upper limit of normal (ULN)
  • Total bilirubin < 1.5 X the institutional ULN (subjects with a higher level of bilirubin due to a familial metabolism will be considered on an individual basis)
  • Life expectancy greater than 2 years
  • Male subjects must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and until study completion (i.e., at least two weeks after dose of study drug)
  • Ability to understand and the willingness to sign a written informed consent document
  • Agree to refrain from use of selenium supplements while on study

Exclusion Criteria:

  • Not willing to remain at RPCI, and in follow up, as required
  • Presence of medical conditions, which in the opinion of the investigators, would compromise either the subject, or the integrity of the data
  • Individuals with a history of active liver or kidney disease within the past 6 months
  • Treatment with an investigational drug within 30 days prior to the dose of study drug
  • Use of prescription or nonprescription drugs, vitamins, or herbal supplements known to change gastric acidity (e.g., H2-antagonists, proton pump inhibitors, antacids) within 3 days of study drug administration
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to MSC (e.g. reaction to other selenium supplements)
  • Subjects who have donated 1 unit of blood within 30 days prior to the first dose of MSC
  • Subjects with a known history of heavy metal exposure, such as lead, mercury, of arsenic
  • ECOG performance status > 1
  • AUA total symptom score > 10 (or any individual symptom score of greater than or equal to 4 will exclude the participant)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489372

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Raymond Bergan Northwestern University
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00489372     History of Changes
Other Study ID Numbers: NCI-2013-00505, NWU04-4-02, I 87406, NCI04-4-02, N01CN35157
Study First Received: June 20, 2007
Last Updated: May 1, 2013
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Additional relevant MeSH terms:
Selenomethylselenocysteine
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013