NCT01261754

A Study of 99mTc-MIP-1404 and 99mTc-MIP-1405 in Patients With Metastatic Prostate Adenocarcinoma and Healthy Volunteers

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Molecular Insight Pharmaceuticals, Inc. · Industry
• Sex: Male
• Age: 21 Years
• Healthy volunteers: Not accepted

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 20.0 (± 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 SPECT/CT 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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	99mTc MIP 1404	Subjects will be administered a single 20 (± 3) mCi intravenous (IV) injection of 99mTc MIP 1404
RADIATION	99mTc MIP 1405	Subjects will be administered a single 20 (± 3) mCi intravenous (IV) injection of 99mTc MIP 1405

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-02-01
• First posted: 2010-12-16
• Last updated: 2015-11-25

Locations

1 site across 1 country: United States