Radiprodil for adults with liver impairment

Phase 1, Open-Label Study to Assess the Pharmacokinetics, Safety, and Tolerability of Radiprodil in Hepatically Impaired Participants

It will test whether a single 15 mg oral dose of radiprodil is processed differently and tolerated safely in adults with mild, moderate, or severe liver impairment compared with healthy adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: GRIN Therapeutics, Inc. (Industry-sponsored)
• Locations: 2 sites (DeSoto, Texas and 1 other locations)
• Trial ID: NCT07457229 on ClinicalTrials.gov

What this trial studies

This Phase 1, open-label study gives a single 15 mg oral dose of radiprodil to up to 40 adults divided into five cohorts by liver function (mild, moderate, or severe hepatic impairment, plus matched healthy controls). Participants will be confined from Day -1 through Day 6 for intensive blood sampling to measure radiprodil and metabolite concentrations and key PK parameters (AUC, Cmax, Tmax, t½, CL/F, Vz/F). Safety and tolerability will be monitored through adverse event reporting, clinical labs, vital signs, ECGs, and physical exams. The data will be used to determine whether dose adjustments are needed for people with impaired liver function.

Who should consider this trial

Good fit: Adults aged 18–75 with stable Child-Pugh Class A, B, or C hepatic impairment, or otherwise healthy adults matched for age, sex, and BMI, who can remain in the clinic for intensive monitoring are ideal candidates.

Not a fit: Patients with unstable or rapidly changing liver disease, other uncontrolled significant medical conditions, recent positive drug tests, or inability to comply with confinement or contraception requirements are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, the results could guide safer, tailored dosing of radiprodil for patients with impaired liver function.

How similar studies have performed: Hepatic impairment PK studies are a standard approach that have successfully guided dose adjustments for many drugs, though radiprodil-specific data are novel.

Eligibility criteria

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.

Where this trial is running

DeSoto, Texas and 1 other locations

• Epic Medical Research — DeSoto, Texas, United States (Recruiting)
• Texas Liver Institute — San Antonio, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Laura Bardell

Conditions Hepatic Impairment; Hepatic impairment; Radiprodil