Radiprodil for adults with liver impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Laura Bardell
• Email: ClinicalTrials@GrinTherapeutics.com
• Phone: +1-877-225-0014

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.