NCT01287845

PET/CT (Positron Emission Tomography/Computed Tomography) Imaging for Safety and Tolerability and Diagnostic Performance of BAY1075553 in Patients With Prostate Cancer and Healthy Volunteers

Open-label, Multi Center PET/CT Study for Investigation of Safety, Tolerability, Biodistribution and Diagnostic Performance of the 18F Labeled PET Tracer BAY1075553 Following a Single Intravenous Administration of 300 MBq in Patients With Prostate Cancer as Well as Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability of the Tracer in PET/CT in Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Life Molecular Imaging SA · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

PET/CT imaging study for evaluation of safety and tolerability and diagnostic performance of BAY1075553 in patients with prostate cancer and in healthy volunteers

Conditions

• Diagnostic Imaging

Interventions

Type	Name	Description
DRUG	BAY1075553	Cancer patients, single intravenous bolus injection of 300 MBq BAY1075553 over 60 seconds on the treatment day 1
DRUG	BAY1075553	Healthy volunteers for dosimetry, single intravenous bolus injection of 300 MBq BAY1075553 over 60 seconds on the treatment day 1

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-10-01
• Completion: 2011-11-01
• First posted: 2011-02-02
• Last updated: 2013-01-21

Locations

2 sites across 2 countries: United States, Austria