Effect of Severe Renal Impairment on Dordaviprone (ONC201) Pharmacokinetics.

ABSTRACT:

Background and objective

Dordaviprone (ONC201) is a novel small molecule with antitumor effects in patients with glioma. The major elimination pathway of dordaviprone is metabolism via cytochrome P450 (CYP) 3A4. This study was designed to assess the effect of severe renal impairment (RI) on dordaviprone pharmacokinetics.

Methods

Eight participants with severe RI and eight participants matched for age, body mass index, and sex, with normal renal function, received a single oral 375-mg dose of dordaviprone. Plasma and urine samples were analyzed for dordaviprone using validated liquid chromatography tandem mass spectrometry methods. Plasma and urine pharmacokinetics, plasma protein binding, and safety profiles were evaluated.

Results

Dordaviprone exposure was increased

SUBMITTER: Faison SL 

PROVIDER: S-EPMC12460856 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature