Ignite Creation Date:
2024-05-05 @ 11:08 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01261754
Status:
COMPLETED
Last Update Posted:
2015-11-25
First Post:
2010-11-18
Brief Title:
A Study of 99mTc-MIP-1404 and 99mTc-MIP-1405 in Patients With Metastatic Prostate Adenocarcinoma and Healthy Volunteers
Sponsor:
Molecular Insight Pharmaceuticals Inc
Organization:
Molecular Insight Pharmaceuticals Inc
Study Overview
Official Title:
A Phase I Study of the PK Tissue Distribution and Metabolism of Small Molecule Inhibitors of Prostate Specific Membrane Antigen 99mTc-MIP-1404 and 99mTc-MIP-1405 in Patients With Metastatic Prostate Adenocarcinoma and Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2015-11
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-blind randomized cross-over design Patients with metastatic prostate adenocarcinoma newly diagnosed high-risk patients with prostate adenocarcinoma and healthy subjects will be administered a single intravenous dose of each of the study drugs 99mTc MIP 1404 and 99mTc MIP 1405 administered approximately 14 to 21 days apart
Detailed Description:
This trial is a single-blind randomized cross-over design Up to six patients with confirmed metastatic prostate adenocarcinoma six newly diagnosed high-risk patients with prostate adenocarcinoma and up to six healthy volunteers will receive 200 3 mCi of intravenously administered 99mTc MIP 1404 or 99mTc MIP 1405 Whole-body planar scintigraphic images will be acquired at various times post-injection over 24 hours A pelvic SPECTCT image will be acquired on the first day Blood and urine will be collected for pharmacokinetic measurements and metabolic analysis over 24 hours Each patient will receive an initial study drug administration and a second study drug administration approximately 14 to 21 days after the first A final follow-up visit will occur approximately 2-3 weeks after the second study drug
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