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

Healthy, no Evidence of Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00489372
• Other study ID #: NCI-2013-00505
• Secondary ID: NCI-2013-00505I
• Status: Completed
• Phase: Phase 1
• First received: June 20, 2007
• Last updated: November 13, 2014
• Start date: July 2007
• Est. completion date: July 2009

Study information

• Verified date: September 2014
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2009
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy, no Evidence of Disease

Intervention

Drug:
• Se-methyl-seleno-L-cysteine
Given orally

Other:
• placebo
Given orally
• pharmacological study
Correlative studies
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Characterization of the pharmacokinetics of MSC	Descriptive statistics calculated for each cohort, using established pharmacokinetic analysis methods.	Up to 24 hours post-dose	No
Secondary	Selenium levels in toenail samples	Summarized graphically.	Up to 24 hours post-dose	No