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Phase 1 Open-Label Study of Radiprodil Pharmacokinetics, Safety, and Tolerability in Hepatically Impaired Participants
Sponsor: GRIN Therapeutics, Inc.
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, moderate, or severe hepatic impairment) or healthy status. Participants will receive a single 15 mg oral dose of radiprodil and remain in the clinical research unit for intensive PK and safety monitoring through Day 6. The primary objective is to characterize the PK profile of radiprodil in participants with hepatic impairment compared with healthy participants. Safety and tolerability will also be assessed. Results from this study will help determine whether dose adjustments are needed in individuals with impaired liver function.
Official title: Phase 1, Open-Label Study to Assess the Pharmacokinetics, Safety, and Tolerability of Radiprodil in Hepatically Impaired Participants
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-03-03
Completion Date
2027-08
Last Updated
2026-03-09
Healthy Volunteers
Yes
Conditions
Interventions
Radiprodil
Radiprodil will be administered as a single oral dose of 15 mg (2.0 mL of 7.5 mg/mL oral suspension) on Day 1 under fed conditions. Participants will fast overnight for at least 10 hours prior to dosing and consume a standard breakfast approximately 30 minutes before administration. Study drug will be administered with approximately 240 mL of water. All participants across cohorts will receive the same single-dose regimen.
Locations (2)
Epic Medical Research
DeSoto, Texas, United States
Texas Liver Institute
San Antonio, Texas, United States