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Liver function may change how radiprodil works – new study aims to find out

NCT ID NCT07457229

Knowledge-focused Sponsor: GRIN Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage study is testing how the drug radiprodil behaves in people with mild, moderate, or severe liver problems compared to healthy adults. About 40 participants will receive a single dose and be monitored for about a week. The goal is to see if liver impairment affects drug levels in the body, which will help guide safe dosing in future studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Radiprodil (oral suspension)
What this could lead to
If successful, this study could help doctors determine the right dose of radiprodil for people with liver problems, making future treatments safer.
What could go wrong
This is a very early Phase 1 study with only 40 people. It is designed to measure drug levels, not to treat any disease, so there is no direct benefit to participants. Liver impairment may affect results unpredictably.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

liver disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatic impairment

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    2 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Epic Medical Research

    RECRUITING

    DeSoto, Texas, 75115, United States

  • Texas Liver Institute

    RECRUITING

    San Antonio, Texas, 78215, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.