Pharmacokinetics, safety, and tolerability of onradivir in participants with severe renal impairment and matched healthy control participants.

ABSTRACT: Onradivir is an influenza A virus RNA polymerase basic protein 2 inhibitor that is currently under development for the treatment of influenza A. Renal impairment can influence drug absorption, metabolism, and transport, potentially altering the pharmacokinetics (PK) of onradivir. This study aimed to provide guidance on clinical dosing for patients with renal impairment by evaluating the impact of renal impairment on the PK, safety, and tolerability of onradivir in a nonrandomized, parallel, single-dose study. Participants with severe renal impairment (estimated glomerular filtration rate 15-29 mL/min) along with healthy participants (n = eight per group) received a single oral dose of 600 mg onradivir. All participants exhibited good safety and tolerability after oral administration

SUBMITTER: Li H 

PROVIDER: S-EPMC12406680 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature