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Radiprodil in Participants With Hepatic Impairment

This study is looking at how the body handles a single dose of radiprodil in adults with different levels of liver problems (hepatic impairment) compared to healthy adults. Radiprodil is being developed for certain brain disorders. Researchers want to understand how much of the drug gets into your system and how long it stays there, as well as checking for any side effects. About 40 adults, aged 18 to 75, will participate. You would receive one dose of radiprodil, and researchers will measure the drug levels in your blood for several days. This helps them understand how to safely use radiprodil in people with liver conditions.

Study design
This is a Phase 1, open-label study involving up to 40 participants. It compares how radiprodil affects people with mild, moderate, or severe liver impairment to healthy individuals.
What's involved
You would be in the clinical research unit from the day before treatment through Day 6. On Day 1, you will receive a single oral dose of radiprodil after fasting overnight and eating a standard breakfast.
Compensation
Not stated in the trial record.
Follow-up
Blood samples will be collected to measure drug levels from pre-dose on Day 1 through Day 6 (120 hours post-dose).

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NCT07457229

Radiprodil in Participants With Hepatic Impairment

Recruiting
PHASE1Ages 18–75Interventional
GRIN Therapeutics, Inc.
~40 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:Radiprodil

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Area Under the Plasma Concentration-Time Curve from Time 0 to Time of Last Quantifiable Concentration (AUClast) of Radiprodil
Measured over Day 1 (pre-dose) through Day 6 (120 hours post-dose)
+7 more outcomes measured

Conditions

Hepatic Impairment

Explore related trials

Liver Failure

Where it's being run

2 sites across 1 states
Texas2

Who to contact

Laura Bardell
[email protected]
+1-877-225-0014
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Area Under the Plasma Concentration-Time Curve from Time 0 to Time of Last Quantifiable Concentration (AUClast) of RadiprodilDay 1 (pre-dose) through Day 6 (120 hours post-dose)

    Plasma AUClast of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.

  • Area Under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUCinf) of RadiprodilDay 1 (pre-dose) through Day 6 (120 hours post-dose)

    Plasma AUCinf of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.

  • Maximum Observed Plasma Concentration (Cmax) of RadiprodilDay 1 (pre-dose) through Day 6 (120 hours post-dose)

    Plasma Cmax of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.

  • Time to Maximum Observed Plasma Concentration (Tmax) of RadiprodilDay 1 (pre-dose) through Day 6 (120 hours post-dose)

    Plasma Tmax of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.

  • Time Before First Quantifiable Plasma Concentration (Tlag) of RadiprodilDay 1 (pre-dose) through Day 6 (120 hours post-dose)

    Plasma Tlag of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.

  • Apparent Total Body Clearance (CL/F) of RadiprodilDay 1 (pre-dose) through Day 6 (120 hours post-dose)

    Apparent total body clearance of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.

  • Apparent Volume of Distribution Based on the Terminal Phase (Vz/F) of RadiprodilDay 1 (pre-dose) through Day 6 (120 hours post-dose)

    Apparent volume of distribution of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.

  • Terminal Elimination Half-Life (t½) of RadiprodilDay 1 (pre-dose) through Day 6 (120 hours post-dose)

    Plasma terminal elimination half-life of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.