RATIONALE AND OBJECTIVES: To evaluate the safety and pharmacokinetics of P792, a new macromolecular blood-pool agent for magnetic resonance imaging (MRI), in nonpatient volunteers. METHODS: This was a single blind, placebo-controlled, ascending-dose study in 32 healthy male volunteers, randomized to receive a single intravenous dose of P792 (0.0065, 0.013, 0.026, and 0.039 mmol/kg). The safety controls consisted of complete pre- and postdose physical examinations, measurement of vital signs, clinical laboratory investigations, and monitoring of adverse events (up to 22 days after injection). For pharmacokinetic analysis, the determination of P792 was performed using the ICP-MS technique for blood and urine samples up to 22 days. RESULTS: No serious adverse events occurred during the study. There were no clinically significant changes in vital signs, or clinical laboratory findings. P792 blood half-life, distribution volume, and renal clearance are consistent with the definition of a rapid clearance blood-pool agent (RCBPA) as defined previously. CONCLUSION: P792 appeared to be a safe and well-tolerated RCBPA in nonpatient subjects. Phase II studies will be conducted to evaluate the efficacy of the blood-pool agent for vascular, perfusion, and permeability imaging in MRI.
RCT Entities:
RATIONALE AND OBJECTIVES: To evaluate the safety and pharmacokinetics of P792, a new macromolecular blood-pool agent for magnetic resonance imaging (MRI), in nonpatient volunteers. METHODS: This was a single blind, placebo-controlled, ascending-dose study in 32 healthy male volunteers, randomized to receive a single intravenous dose of P792 (0.0065, 0.013, 0.026, and 0.039 mmol/kg). The safety controls consisted of complete pre- and postdose physical examinations, measurement of vital signs, clinical laboratory investigations, and monitoring of adverse events (up to 22 days after injection). For pharmacokinetic analysis, the determination of P792 was performed using the ICP-MS technique for blood and urine samples up to 22 days. RESULTS: No serious adverse events occurred during the study. There were no clinically significant changes in vital signs, or clinical laboratory findings. P792 blood half-life, distribution volume, and renal clearance are consistent with the definition of a rapid clearance blood-pool agent (RCBPA) as defined previously. CONCLUSION: P792 appeared to be a safe and well-tolerated RCBPA in nonpatient subjects. Phase II studies will be conducted to evaluate the efficacy of the blood-pool agent for vascular, perfusion, and permeability imaging in MRI.
Authors: Thomas Thouet; Bernhard Schnackenburg; Thomas Kokocinski; Eckart Fleck; Eike Nagel; Sebastian Kelle Journal: ScientificWorldJournal Date: 2012-03-12