Pharmacokinetics, Pharmacodynamics Profile and Tolerance of P03277 in Healthy Subjects and Patients With Brain Lesions

Phase 1/2 Completed 142 enrolled Guerbet

RandomizedSequentialTriple-blindDiagnostic

Summary

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.

Timeline

Start: 2013-11-25
Primary completion: 2015-04-17
Completion: 2015-04-17

Publications

Hao J, Bourrinet P, Desche P. Assessment of Pharmacokinetic, Pharmacodynamic Profile, and Tolerance of Gadopiclenol, A New High Relaxivity GBCA, in Healthy Subjects and Patients With Brain Lesions (Phase I/IIa Study). Invest Radiol. 2019 Jul;54(7):396-402. doi: 10.1097/RLI.0000000000000556.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gadopiclenol	Diagnostic / imaging agent	0.025 unknown	Intravenous
Subject	Gadopiclenol	Diagnostic / imaging agent	0.05 unknown	Intravenous
Subject	Gadopiclenol	Diagnostic / imaging agent	0.075 unknown	Intravenous
Subject	Gadopiclenol	Diagnostic / imaging agent	0.1 unknown	Intravenous
Subject	Gadopiclenol	Diagnostic / imaging agent	0.2 unknown	Intravenous
Subject	Gadopiclenol	Diagnostic / imaging agent	0.3 unknown	Intravenous

Indications

No indication recorded.