Ignite Creation Date:
2024-05-05 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 9:52 AM
Study NCT ID:
NCT00712829
Status:
COMPLETED
Last Update Posted:
2011-10-12
First Post:
2008-07-08
Brief Title:
Study to Evaluate the Safety Pharmacokinetics Tissue Distribution Metabolism and Dosimetry of Two Prostate Cancer Imaging Agents
Sponsor:
Molecular Insight Pharmaceuticals Inc
Organization:
Molecular Insight Pharmaceuticals Inc
Study Overview
Official Title:
A Phase I Study Evaluating the Safety Pharmacokinetics Tissue Distribution Metabolism of Small Molecule Inhibitors of Prostate Specific Membrane Antigen Determination of I-123 Radiation Dosimetry for 123-I-MIP-1072 and 123-I-MIP-1095
Status:
COMPLETED
Status Verified Date:
2011-10
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 is a single blinded randomized cross-over design Up to 12 patients will be randomly administered a single 100 mCi dose of 123I-MIP-1072 or 123I-MIP-1095 study drugs The second alternate study drug will be administered approximately 14 days after the first A final follow-up visit will occur approximately 2 weeks after the injection of the alternate study drug
Detailed Description:
None
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