Radiprodil in Participants With Hepatic Impairment

NCT07457229 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: RAD-GRIN-505
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Keywords

Hepatic impairment; Radiprodil

Outcome Measures

Primary Outcomes (8)

• Area Under the Plasma Concentration-Time Curve from Time 0 to Time of Last Quantifiable Concentration (AUClast) of Radiprodil

  Plasma AUClast of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.

  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

  Plasma AUCinf of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.

  Day 1 (pre-dose) through Day 6 (120 hours post-dose)

• Maximum Observed Plasma Concentration (Cmax) of Radiprodil

  Plasma Cmax of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.

  Day 1 (pre-dose) through Day 6 (120 hours post-dose)

• Time to Maximum Observed Plasma Concentration (Tmax) of Radiprodil

  Plasma Tmax of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.

  Day 1 (pre-dose) through Day 6 (120 hours post-dose)

• Time Before First Quantifiable Plasma Concentration (Tlag) of Radiprodil

  Plasma Tlag of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.

  Day 1 (pre-dose) through Day 6 (120 hours post-dose)

• Apparent Total Body Clearance (CL/F) of Radiprodil

  Apparent total body clearance of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.

  Day 1 (pre-dose) through Day 6 (120 hours post-dose)

• Apparent Volume of Distribution Based on the Terminal Phase (Vz/F) of Radiprodil

  Apparent volume of distribution of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.

  Day 1 (pre-dose) through Day 6 (120 hours post-dose)

• Terminal Elimination Half-Life (t½) of Radiprodil

  Plasma terminal elimination half-life of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.

  Day 1 (pre-dose) through Day 6 (120 hours post-dose)

Secondary Outcomes (23)

• Area Under the Plasma Concentration-Time Curve from Time 0 to Time of Last Quantifiable Concentration (AUClast) of FBPO

  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 FBPO

  Day 1 (pre-dose) through Day 6 (120 hours post-dose)

• Maximum Observed Plasma Concentration (Cmax) of FBPO

  Day 1 (pre-dose) through Day 6 (120 hours post-dose)

• Time to Maximum Observed Plasma Concentration (Tmax) of FBPO

  Day 1 (pre-dose) through Day 6 (120 hours post-dose)

• Time Before First Quantifiable Plasma Concentration (Tlag) of FBPO

  Day 1 (pre-dose) through Day 6 (120 hours post-dose)

Study Arms (5)

Mild Hepatic Impairment

EXPERIMENTAL

Participants with mild hepatic impairment (Child-Pugh Class A).

Drug: Radiprodil

Moderate Hepatic Impairment

EXPERIMENTAL

Participants with moderate hepatic impairment (Child-Pugh Class B).

Drug: Radiprodil

Healthy Participants (Matched to Mild/Moderate)

EXPERIMENTAL

Healthy participants matched to the mild and moderate hepatic impairment cohorts by age, sex, and body mass index where feasible.

Drug: Radiprodil

Severe Hepatic Impairment

EXPERIMENTAL

Participants with severe hepatic impairment (Child-Pugh Class C).

Drug: Radiprodil

Healthy Participants (Matched to Severe)

EXPERIMENTAL

Healthy participants matched to the severe hepatic impairment cohort by age, sex, and body mass index where feasible.

Drug: Radiprodil

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.

Also known as: RGH-896, Radiprodil oral suspension

Healthy Participants (Matched to Mild/Moderate); Healthy Participants (Matched to Severe); Mild Hepatic Impairment; Moderate Hepatic Impairment; Severe Hepatic Impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GRIN Therapeutics, Inc.: lead

Study Sites (2)

Epic Medical Research

DeSoto, Texas, 75115, United States

RECRUITING

Texas Liver Institute

San Antonio, Texas, 78215, United States

RECRUITING

MeSH Terms

Interventions

radiprodil

Central Study Contacts

Laura Bardell

CONTACT

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

Aneeta Saxena

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be assigned to parallel cohorts based on hepatic function (mild, moderate, or severe hepatic impairment) or healthy status. All participants will receive a single oral dose of radiprodil 15 mg. Healthy participants will be enrolled to match hepatically impaired cohorts by age, sex, and body mass index where feasible. Cohorts will be initiated sequentially following Safety Review Committee review of available safety and pharmacokinetic data, but participants will not cross over between cohorts.

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 9, 2026
• Study Start: March 3, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)