Know Cancer

or
forgot password

PHASE I STUDY OF SINGLE ORAL DOSE OF Se-METHYL-SELENO-L-CYSTEINE (MSC) IN ADULT MEN


Phase 1
18 Years
70 Years
Open (Enrolling)
Male
Healthy, no Evidence of Disease

Thank you

Trial Information

PHASE I STUDY OF SINGLE ORAL DOSE OF Se-METHYL-SELENO-L-CYSTEINE (MSC) IN ADULT MEN


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.


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Clinical toxicity in healthy adult male volunteers, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v3.0

Outcome Description:

Summarized using descriptive statistics.

Outcome Time Frame:

Up to 30 days

Safety Issue:

Yes

Principal Investigator

Raymond Bergan

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2013-00505

NCT ID:

NCT00489372

Start Date:

July 2007

Completion Date:

Related Keywords:

  • Healthy, no Evidence of Disease

Name

Location

Northwestern UniversityChicago, Illinois  60611