Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00489372
Status:
COMPLETED
Last Update Posted:
2014-11-14
First Post:
2007-06-20
Brief Title:
Se-Methyl-Seleno-L- Cysteine MSC in Treating Healthy Patients
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of Single Oral Dose of Se-Methyl-Seleno-L-Cysteine MSC in Adult Men
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2013-00505 | REGISTRY | None | None |
| I 87406 | None | None | None |
| NCI04-4-02 | None | None | None |
| NWU04-4-02 | OTHER | None | None |
| NWU04-4-02 | OTHER | None | None |
| P30CA060553 | NIH | None | None |
| N01CN35157 | NIH | DCP | httpsreporternihgovquickSearchN01CN35157 |