Actively Recruiting
Radiprodil in Participants With Hepatic Impairment
Led by GRIN Therapeutics, Inc. · Updated on 2026-05-08
40
Participants Needed
2
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Radiprodil in Participants With Hepatic Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 to 75 years
- Body mass index within protocol-specified range
- Stable mild (Child-Pugh Class A), moderate (Child-Pugh Class B), or severe (Child-Pugh Class C) hepatic impairment for impaired cohorts
- Medically healthy status with no significant abnormalities for healthy cohort
- Willingness and ability to comply with study procedures and confinement
- Use of highly effective contraception by participants of childbearing potential
- Provision of written informed consent before any study procedures
You will not qualify if you...
- History or presence of significant medical conditions interfering with study or results
- Positive test for drugs of abuse, alcohol, or cotinine at screening or check-in
- Positive serology for HIV, hepatitis B surface antigen, or hepatitis C virus
- Significant abnormal lab values, vital signs, or ECG findings at screening or Day -1
- Use of prohibited medications or substances affecting radiprodil metabolism
- Pregnancy or breastfeeding
- Participation in another clinical study or receipt of investigational product within specified timeframe
- Any condition judged by investigator or sponsor to make participation unsafe or confounding
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Trial Site Locations
Total: 2 locations
1
Epic Medical Research
DeSoto, Texas, United States, 75115
Actively Recruiting
2
Texas Liver Institute
San Antonio, Texas, United States, 78215
Actively Recruiting
Research Team
L
Laura Bardell
CONTACT
A
Aneeta Saxena
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
5
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