Radiprodil in Participants With Hepatic Impairment
GRIN Therapeutics, Inc. · NCT07457229
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–75 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 1
- Target enrollment
- 40
- US sites recruiting
- 2
- Study start
- March 3, 2026
- Record last updated
- May 8, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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.
Being studied: Radiprodil
Conditions: Hepatic Impairment
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
Epic Medical Research
DeSoto, TX 75115
Site contact: Ketul Shah, CRC · 979-344-1980 · kshah@epicmedresearch.com
Texas Liver Institute
San Antonio, TX 78215
Site contact: Bryan Bernal, CRC · (210) 572-4986 · bbernal@txliver.com
Study contacts (from the official record)
- Laura Bardell · +1-877-225-0014 · ClinicalTrials@GrinTherapeutics.com
- Aneeta Saxena
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