Recruiting
Phase 1

Radiprodil

Sponsor:

GRIN Therapeutics, Inc.

Code:

NCT07457229

Conditions

Hepatic Impairment

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Radiprodil

Study Details

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, 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.

Conditions

Hepatic Impairment

Study ID

NCT07457229

Start date

Mar 3, 2026

Status verified date

May, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Male or female participants aged 18 to 75 years, inclusive, at Screening.
  • Body mass index (BMI) within the range specified in the protocol.
  • Participants with hepatic impairment must have stable mild (Child-Pugh Class A), moderate (Child-Pugh Class B), or severe (Child-Pugh Class C) hepatic impairment, as applicable to cohort assignment.
  • Healthy participants must be medically healthy with no clinically significant abnormalities as determined by the investigator.
  • Participants must be willing and able to comply with all study procedures and confinement requirements.
  • Participants of childbearing potential must agree to use highly effective contraception methods as defined in the protocol.
  • Participants must provide written informed consent prior to any study procedures

Exclusion Criteria:

  • History or presence of clinically significant medical conditions that could interfere with study participation or interpretation of results.
  • Positive test for drugs of abuse, alcohol, or cotinine (where applicable) at Screening or check-in.
  • Positive serology for HIV, hepatitis B surface antigen, or hepatitis C virus.
  • Clinically significant abnormal laboratory values, vital signs, or ECG findings at Screening or Day -1, as judged by the investigator.
  • Use of prohibited concomitant medications or substances that may interfere with radiprodil metabolism.
  • Pregnant or breastfeeding women.
  • Participation in another clinical study or receipt of an investigational product within the protocol-specified timeframe prior to dosing.
  • Any condition that, in the opinion of the investigator or sponsor, would make participation not in the best interest of the participant or could confound study results.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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.

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.

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) ]
  • Area Under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUCinf) of Radiprodil [ Time Frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose) ]
  • Maximum Observed Plasma Concentration (Cmax) of Radiprodil [ Time Frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose) ]
  • Time to Maximum Observed Plasma Concentration (Tmax) of Radiprodil [ Time Frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose) ]
  • Time Before First Quantifiable Plasma Concentration (Tlag) of Radiprodil [ Time Frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose) ]
  • Apparent Total Body Clearance (CL/F) of Radiprodil [ Time Frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose) ]
  • Apparent Volume of Distribution Based on the Terminal Phase (Vz/F) of Radiprodil [ Time Frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose) ]
  • Terminal Elimination Half-Life (t½) of Radiprodil [ Time Frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose) ]

Central Contacts and Locations

Central contacts

Laura Bardell

+1-877-225-0014ClinicalTrials@GrinTherapeutics.com

Locations

Epic Medical Research

Recruiting

DeSoto, Texas, United States, 75115

Contacts

Ketul Shah, CRC

979-344-1980kshah@epicmedresearch.com

Texas Liver Institute

Recruiting

San Antonio, Texas, United States, 78215

Contacts

Bryan Bernal, CRC

(210) 572-4986bbernal@txliver.com

More Information

Sponsor

GRIN Therapeutics, Inc.

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • Hepatic impairment
  • Radiprodil

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by GRIN Therapeutics, Inc. on 2026-05-08.