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)

• Published in: Investigative radiology Vol. 54; no. 7; p. 396
• Main Authors: Hao, Jing, Bourrinet, Philippe, Desché, Pierre
• Format: Journal Article
• Language: English
• Published: United States 01.07.2019
• Subjects: Adolescent; Adult; Area Under Curve; Azabicyclo Compounds - pharmacokinetics; Azabicyclo Compounds - pharmacology; Brain - diagnostic imaging; Brain - drug effects; Brain - metabolism; Brain Neoplasms - diagnostic imaging; Brain Neoplasms - metabolism; Contrast Media - pharmacokinetics; Contrast Media - pharmacology; Dose-Response Relationship, Drug; Double-Blind Method; Female; Gadolinium - pharmacokinetics; Gadolinium - pharmacology; Healthy Volunteers; Humans; Magnetic Resonance Imaging; Male; Middle Aged; Young Adult

The aim of this study was to evaluate the pharmacokinetics, safety profile, and pharmacodynamics of gadopiclenol, a new high relaxivity macrocyclic gadolinium-based contrast agent, in healthy subjects and patients with brain lesions. This was a single ascending dose phase I/IIa study. Phase I was do...