NCT00712829

Study to Evaluate the Safety, Pharmacokinetics, Tissue Distribution, Metabolism and Dosimetry of Two Prostate Cancer Imaging Agents

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Molecular Insight Pharmaceuticals, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single blinded, randomized, cross-over design. Up to 12 patients will be randomly administered a single 10.0 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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	123-I-MIP-1072	10 mCi intravenous injection given one time during the study
DRUG	123-I-MIP-1095	10 mCi intravenous injection given one time during the study

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2008-07-10
• Last updated: 2011-10-12

Locations

3 sites across 1 country: United States