Healthy, no Evidence of DiseasePhase 1NCT00489372
Se-Methyl-Seleno-L- Cysteine (MSC) in Treating Healthy Patients
A Phase 1 study testing Se-methyl-seleno-L-cysteine, pharmacological study and laboratory biomarker analysis in people with Healthy, no Evidence of Disease, run by National Cancer Institute (NCI) at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Healthy, no Evidence of Disease
- What is being tested?
- Se-methyl-seleno-L-cysteine, pharmacological study and laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2007to Jul 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
Northwestern University
Chicago, Illinois, 60611
About this study
Official title: Phase I Study of Single Oral Dose of Se-Methyl-Seleno-L-Cysteine (MSC) in Adult Men
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the toxicity of MSC, given to healthy adult males as a single oral dose.
SECONDARY OBJECTIVES:
- 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
- Healthy, no Evidence of Disease
- Being tested
- Se-methyl-seleno-L-cysteine, placebo, pharmacological study, laboratory biomarker analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Se-methyl-seleno-L-cysteineDrug
Also called methylselenocysteine, MSC
Given orally
placeboOther
Also called PLCB
Given orally
Also called pharmacological studies
Correlative studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (placebo) | Placebo comparator | Participants receive oral placebo on day 1. Receives: 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. Receives: Drug: Se-methyl-seleno-L-cysteine; Other: pharmacological study; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 30 days
Secondary outcomes (2)
Characterization of the pharmacokinetics of MSC
Descriptive statistics calculated for each cohort, using established pharmacokinetic analysis methods.
Measured: Up to 24 hours post-dose
Selenium levels in toenail samples
Summarized graphically.
Measured: Up to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionMar 2008
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy, no Evidence of DiseaseStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Raymond Bergan, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489372
- Sponsor's protocol ID
- NCI-2013-00505
- Other IDs
- NCI-2013-00505, I 87406, NCI04-4-02, NWU04-4-02, NWU04-4-02, P30CA060553, N01CN35157
- Status last verified
- Sep 2014
- First submitted
- 20 Jun 2007
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Single Oral Dose of Se-Methyl-Seleno-L-Cysteine (MSC) in Adult Men
- ClinicalTrials.gov ID
- NCT00489372
- Acronym / sponsor ID
- NCI-2013-00505
- Conditions
- Healthy, no Evidence of Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jul 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 21 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
PRIMARY OBJECTIVES:
- To evaluate the toxicity of MSC, given to healthy adult males as a single oral dose.
SECONDARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (placebo) | Placebo comparator | Other: placebo, Other: pharmacological study, Other: laboratory biomarker analysisParticipants receive oral placebo on day 1. |
| Arm II (Se-methyl-seleno-L-cysteine) | Experimental | Drug: Se-methyl-seleno-L-cysteine, Other: pharmacological study, Other: laboratory biomarker analysisParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Total body weight between 50 and 115 kg
- Hgb > 12 gm/dl
- Platelets > 100,000/μL
- ANC > 1000/μL
- Creatinine < 1.5 mg/dl
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Se-methyl-seleno-L-cysteineAlso: methylselenocysteine, MSCGiven orally | Drug | Arm II (Se-methyl-seleno-L-cysteine) |
| placeboAlso: PLCBGiven orally | Other | Arm I (placebo) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Arm I (placebo), Arm II (Se-methyl-seleno-L-cysteine) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (placebo), Arm II (Se-methyl-seleno-L-cysteine) |
Primary outcome
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
Summarized using descriptive statistics.
2 secondary outcomes
Characterization of the pharmacokinetics of MSC
Time frame: Up to 24 hours post-dose
Selenium levels in toenail samples
Time frame: Up to 24 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2014.
Related trials for Healthy, no Evidence of Disease
Active, not recruiting
Comparing the Reliability of Expressed Prostatic Secretion (EPS) and Post Massage Urine (PMU) for the Prediction of Prostate Cancer Biopsy Outcome
Conditions Influencing Health Status, Healthy
Active, not recruiting
The Parents in Appalachia Receive Education Needed for Teen Project
Healthy, Human Papilloma Virus Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond Bergan principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Se-methyl-seleno-L-cysteine, pharmacological study and laboratory biomarker analysis in people with Healthy, no Evidence of Disease, run by National Cancer Institute (NCI) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2014.