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

NCT00489372 | Completed Phase 1 DMC

• 6 other identifiers: NCI-2013-00505I 87406NCI04-4-02NWU04-4-02P30CA060553N01CN35157
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Healthy, no Evidence of Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 30 days

Secondary Outcomes (2)

• Characterization of the pharmacokinetics of MSC

  Up to 24 hours post-dose

• Selenium levels in toenail samples

  Up to 24 hours post-dose

Study Arms (2)

Arm I (placebo)

PLACEBO COMPARATOR

Participants receive oral placebo on day 1.

Other: placebo; Other: pharmacological study; Other: laboratory biomarker analysis

Arm II (Se-methyl-seleno-L-cysteine)

EXPERIMENTAL

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.

Drug: Se-methyl-seleno-L-cysteine; Other: pharmacological study; Other: laboratory biomarker analysis

Interventions

Se-methyl-seleno-L-cysteine DRUG

Given orally

Also known as: methylselenocysteine, MSC

Arm II (Se-methyl-seleno-L-cysteine)

placebo OTHER

Given orally

Also known as: PLCB

Arm I (placebo)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Arm I (placebo); Arm II (Se-methyl-seleno-L-cysteine)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (placebo); Arm II (Se-methyl-seleno-L-cysteine)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Interventions

selenomethylselenocysteine

Study Officials

• Raymond Bergan

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2007
• First Posted: June 21, 2007
• Study Start: July 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: July 1, 2009
• Last Updated: November 14, 2014

Record last verified: 2014-09

Locations

US (2)