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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-07-31

Brief Summary

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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

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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

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Healthy, no Evidence of Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm I (placebo)

Participants receive oral placebo on day 1.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Given orally

pharmacological study

Intervention Type OTHER

Correlative studies

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

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.

Group Type EXPERIMENTAL

Se-methyl-seleno-L-cysteine

Intervention Type DRUG

Given orally

pharmacological study

Intervention Type OTHER

Correlative studies

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Interventions

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Se-methyl-seleno-L-cysteine

Given orally

Intervention Type DRUG

placebo

Given orally

Intervention Type OTHER

pharmacological study

Correlative studies

Intervention Type OTHER

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

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methylselenocysteine MSC PLCB pharmacological studies

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raymond Bergan

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Countries

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United States