Clinical Trial: Phase 1 Open-Label Study of Radiprodil Pharmacokinetics, Safety, and Tolerability in Hepatically Impaired Participants

U.S., March 10 -- ClinicalTrials.gov registry received information related to the study (NCT07457229) titled 'Phase 1 Open-Label Study of Radiprodil Pharmacokinetics, Safety, and Tolerability in Hepatically Impaired Participants' on Feb. 26.

Brief Summary: This Phase 1, open-label study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of radiprodil in adults with varying degrees of hepatic impairment compared with healthy participants. Radiprodil is being developed as a potential treatment for GRIN-related neurodevelopmental disorders, tuberous sclerosis complex, and focal cortical dysplasia.

Approximately 40 adults aged 18 to 75 years will be enrolled into five cohorts based on liver function (mild,...