Radiprodil for Liver Disease

Recruiting at 1 trial location

Overseen By Laura Bardell

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: GRIN Therapeutics, Inc.

Must not be taking: Drugs of abuse, alcohol

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 days

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

My liver condition is stable, even if it is mild, moderate, or severe.

Participants of childbearing potential must agree to use highly effective contraception methods as defined in the protocol

Healthy participants must be medically healthy with no clinically significant abnormalities as determined by the investigator

Exclusion Criteria

History or presence of clinically significant medical conditions that could interfere with study participation or interpretation of results

Positive serology for HIV, hepatitis B surface antigen, or hepatitis C virus

Positive test for drugs of abuse, alcohol, or cotinine (where applicable) at Screening or check-in

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single 15 mg oral dose of radiprodil and are monitored for pharmacokinetics, safety, and tolerability

6 days

Continuous stay in clinical research unit

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Radiprodil

How Is the Trial Designed?

Group I: Severe Hepatic Impairment Experimental Treatment 1 Intervention

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

Group II: Moderate Hepatic Impairment Experimental Treatment 1 Intervention

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

Group III: Mild Hepatic Impairment Experimental Treatment 1 Intervention

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

Group IV: Healthy Participants (Matched to Severe) Experimental Treatment 1 Intervention

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

Group V: Healthy Participants (Matched to Mild/Moderate) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

GRIN Therapeutics, Inc.

Lead Sponsor

Trials

2

Recruited

50+