Topical administration of regorafenib eye drops: phase I dose‐escalation study in healthy volunteers

• Published in: British journal of clinical pharmacology Vol. 84; no. 5; pp. 865 - 875
• Main Authors: Zimmermann, Torsten, Höchel, Joachim, Becka, Michael, Boettger, Michael K., Rohde, Beate, Schug, Barbara, Kunert, Kathleen S., Donath, Frank
• Format: Journal Article
• Language: English
• Published: England John Wiley and Sons Inc 01.05.2018
• Subjects: Administration, Ophthalmic; Administration, Oral; Adolescent; Adult; Clinical Trials; convenience; Dose-Response Relationship, Drug; Double-Blind Method; eye drops; Healthy Volunteers; Humans; Male; Middle Aged; neovascular age‐related macular degeneration; Ophthalmic Solutions - adverse effects; Ophthalmic Solutions - pharmacokinetics; pharmacokinetics; Phenylurea Compounds - administration & dosage; Phenylurea Compounds - adverse effects; Phenylurea Compounds - blood; Phenylurea Compounds - pharmacokinetics; Protein Kinase Inhibitors - administration & dosage; Protein Kinase Inhibitors - adverse effects; Protein Kinase Inhibitors - blood; Protein Kinase Inhibitors - pharmacokinetics; Pyridines - administration & dosage; Pyridines - adverse effects; Pyridines - blood; Pyridines - pharmacokinetics; regorafenib; safety; Young Adult; eye drops; neovascular age-related macular degeneration; pharmacokinetics; convenience; regorafenib; safety

Aim Regorafenib is a multikinase inhibitor under investigation for use in neovascular age‐related macular degeneration. In this phase I study, regorafenib eye drops were administered to healthy volunteers to provide information on safety, tolerability and systemic exposure. Methods This was a single...