Radiprodil in Participants With Hepatic Impairment

Part of paid clinical trials in DeSoto, Texas.

Sponsor
GRIN Therapeutics, Inc.
Study ID
NCT07457229
Phase
PHASE1
Status
Recruiting
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Conditions

  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Radiprodil — DRUG
    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.

Study Details

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.

Key Dates

Start date
Mar 3, 2026
Status verified
May 2026
Primary completion
May 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Mild Hepatic Impairment
    Participants with mild hepatic impairment (Child-Pugh Class A).
  • Experimental: Moderate Hepatic Impairment
    Participants with moderate hepatic impairment (Child-Pugh Class B).
  • Experimental: Healthy Participants (Matched to Mild/Moderate)
    Healthy participants matched to the mild and moderate hepatic impairment cohorts by age, sex, and body mass index where feasible.
  • Experimental: Severe Hepatic Impairment
    Participants with severe hepatic impairment (Child-Pugh Class C).
  • Experimental: Healthy Participants (Matched to Severe)
    Healthy participants matched to the severe hepatic impairment cohort by age, sex, and body mass index where feasible.

Primary Outcome Measure

Area Under the Plasma Concentration-Time Curve from Time 0 to Time of Last Quantifiable Concentration (AUClast) of Radiprodil [ Time Frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Epic Medical ResearchDeSotoTexas75115
Ketul Shah, CRC
[email protected]
979-344-1980
Haresh Boghara, MD
Texas Liver InstituteSan AntonioTexas78215
Bryan Bernal, CRC
[email protected]
(210) 572-4986
Eric Lawtiz, MD

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