💬In plain words
What the trial is, and whether it could suit you
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 asse
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
Epic Medical Research
DeSoto, United States
Texas Liver Institute
San Antonio, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
HealthTeky