A Phase 1 Study to Evaluate the Absorption, Metabolism, and Disposition of Dordaviprone in Healthy Adult Participants

• Published in: Clinical pharmacology in drug development Vol. 14; no. 7; p. 549
• Main Authors: Teffera, Yohannes, Tippin, Tim, Bartkus, Angela, de Castro, Francine A, Faison, Shamia L, Morrison, Marion, Mullin, Mark J, Naderer, Odin
• Format: Journal Article
• Language: English
• Published: United States 01.07.2025
• Subjects: Administration, Oral; Adult; Antineoplastic Agents - administration & dosage; Antineoplastic Agents - pharmacokinetics; Antineoplastic Agents - urine; Area Under Curve; Chromatography, Liquid; Feces - chemistry; Healthy Volunteers; Humans; Male; Middle Aged; Pyridones - administration & dosage; Pyridones - pharmacokinetics; Tandem Mass Spectrometry; Young Adult; metabolism; excretion; mass balance; ONC201; dordaviprone

Dordaviprone (ONC201) is a novel, small-molecule imipridone with antitumor activity in patients with a glioma. Six healthy male participants received a single 625-mg (100-µCi) oral dose of [ C]-dordaviprone. Blood, plasma, urine, and feces were collected up to 288 hours after dosing and analyzed by...