P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
Completed
Guerbet
Phase 2
2016-06-01
The purpose of this study was to determine a safe and effective dose of a new
gadolinium-based contrast agent (GBCA) P03277 based on the Contrast to Noise Ratio (CNR) when
comparing with gadobenate dimeglumine (MultiHance®) at 0.1 mmol/kg body weight (BW).
Contrast to Noise Ratio (CNR), a well-known quantitative parameter directly related to
contrast medium/GBCA efficacy, was chosen as the primary endpoint in order to have a precise
determination of P03277 clinical dose.
This was a multi-center, international, prospective, double-blind, randomized, controlled,
parallel dose groups, cross-over with comparator study in male and female subjects presenting
with known or highly suspected focal areas of disruption of the Blood Brain Barrier including
at least one expected enhancing lesion of minimum 5 mm, who were scheduled to undergo a
routine contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System.
Pharmacokinetics, Pharmacodynamics Profile and Tolerance of P03277 in Healthy Subjects and Patients With Brain Lesions
Completed
Guerbet
Phase 1/Phase 2
2013-11-25
The primary objective of this study was to evaluate the safety (clinical and biological) and
pharmacokinetics (plasma and urine) profile of P03277 following single administration at
ascending dose levels in healthy subjects.
The study is a Phase I, Single center, Randomized, Cross-over Double-blind Placebo-controlled
and Open-label Positive-controlled (moxifloxacin) in healthy volunteers.
The primary objective is to assess the cardiac safety after administration of P03277 to 48
healthy volunteers at dose of 0.1 mmol/kg (anticipated clinical dose) and 0.3 mmol/kg
(supra-clinical dose) by evaluating the QT and QTc intervals.
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