CLINICAL TRIALS PROFILE FOR GADOPICLENOL
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All Clinical Trials for GADOPICLENOL
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT02633501 ↗ | 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. |
| NCT03603106 ↗ | 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. |
| NCT03657264 ↗ | Cardiac Safety Evaluation of P03277 | Completed | Guerbet | Phase 1 | 2017-08-21 | 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. |
| NCT03657784 ↗ | Pharmacokinetics, Dialysability and Safety of P03277 in Healthy Volunteers and in Patients With Impaired Renal Function | Completed | Guerbet | Phase 1 | 2017-10-13 | This is an open-label, non-randomized, successive cohorts design, multicenter, single dose phase I study. The primary objectives are: - to evaluate the pharmacokinetics (plasma and urine) profile of P03277 following single intravenous injection (0.1 mmol/kg body weight) in patients with mild to severe renal impairment and in healthy volunteers with normal renal function used as reference. - to assess dialysability of P03277 following a single intravenous injection (0.1 mmol/kg body weight) in patients with end stage renal disease requiring hemodialysis. |
| NCT03749252 ↗ | Pharmacokinetics, Safety and Efficacy of P03277 in Pediatric Patients Undergoing Central Nervous System Contrast-enhanced MRI | Completed | Guerbet | Phase 2 | 2018-11-06 | This is a pharmacokinetics (PK), open-label, uncontrolled, multicenter phase II trial with age-staggered approach. The primary objective is to evaluate the pharmacokinetic profile of P03277 in plasma following single intravenous injection of 0.05 mmol/kg body weight in pediatric population aged from 2 to 17 years. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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