Hepatic ImpairmentPhase 1NCT07457229
Radiprodil in Participants With Hepatic Impairment
A Phase 1 study testing Radiprodil in people with Hepatic Impairment, run by GRIN Therapeutics, Inc. at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- Radiprodil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Mar 2026to Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Aneeta Saxena contact
United States2 sites, 2 recruiting
- Recruiting
Epic Medical Research
DeSoto, Texas, 75115
Ketul Shah, CRC, 979-344-1980, kshah@epicmedresearch.com
Haresh Boghara, MD
- Recruiting
Texas Liver Institute
San Antonio, Texas, 78215
Bryan Bernal, CRC, (210) 572-4986, bbernal@txliver.com
Eric Lawtiz, MD
About this study
Official title: Phase 1, Open-Label Study to Assess the Pharmacokinetics, Safety, and Tolerability of Radiprodil in Hepatically Impaired Participants
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.
Read the detailed description
This is a Phase 1, open-label, two-arm study designed to assess the pharmacokinetics (PK), safety, and tolerability of a single oral dose of radiprodil in adults with varying degrees of hepatic impairment compared with matched healthy participants.
Up to 40 participants aged 18 to 75 years will be enrolled across five cohorts. Participants will include individuals with mild (Child-Pugh Class A), moderate (Child-Pugh Class B), or severe (Child-Pugh Class C) hepatic impairment, as well as healthy participants matched for age, sex, and body mass index where feasible.
The study consists of a Screening Period (Days -28 to -2), check-in on Day -1, and a Treatment Period. Participants will be confined to the clinical research unit from Day -1 through completion of study assessments on Day 6. On Day 1, all participants will receive a single oral dose of radiprodil 15 mg administered as an oral suspension.
Serial blood samples will be collected to determine plasma concentrations of radiprodil and its major metabolites. Key PK parameters include area under the concentration-time curve (AUC), maximum observed concentration (Cmax), time to maximum concentration (Tmax), terminal half-life (t½), apparent clearance (CL/F), and apparent volume of distribution (Vz/F).
Safety and tolerability will be evaluated throughout the study by monitoring adverse events, vital signs, electrocardiograms, clinical laboratory tests, physical examinations, and Columbia Suicide Severity Rating Scale assessments.
Hepatic impairment can alter the metabolism and exposure of many drugs. Because radiprodil is primarily eliminated via hepatic metabolism, this study is intended to characterize the effect of liver impairment on radiprodil exposure and to inform potential dosing recommendations for future clinical use.
- Conditions
- Hepatic Impairment
- Being tested
- Radiprodil
- Keywords
- Hepatic impairment, Radiprodil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiprodilDrug
Also called RGH-896, Radiprodil oral suspension
Radiprodil will be administered as a single oral dose of 15 mg (2.0 mL of 7.5 mg/mL oral suspension) on Day 1 under fed conditions. Participants will fast overnight for at least 10 hours prior to dosing and consume a standard breakfast approximately 30 minutes before administration. Study drug will be administered with approximately 240 mL of water. All participants across cohorts will receive the same single-dose regimen.
| Study group | Role | What they receive |
|---|---|---|
| Mild Hepatic Impairment | Experimental | Participants with mild hepatic impairment (Child-Pugh Class A). Receives: Drug: Radiprodil |
| Moderate Hepatic Impairment | Experimental | Participants with moderate hepatic impairment (Child-Pugh Class B). Receives: Drug: Radiprodil |
| Healthy Participants (Matched to Mild/Moderate) | Experimental | Healthy participants matched to the mild and moderate hepatic impairment cohorts by age, sex, and body mass index where feasible. Receives: Drug: Radiprodil |
| Severe Hepatic Impairment | Experimental | Participants with severe hepatic impairment (Child-Pugh Class C). Receives: Drug: Radiprodil |
| Healthy Participants (Matched to Severe) | Experimental | Healthy participants matched to the severe hepatic impairment cohort by age, sex, and body mass index where feasible. Receives: Drug: Radiprodil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-Time Curve from Time 0 to Time of Last Quantifiable Concentration (AUClast) of Radiprodil
Plasma AUClast of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.
Measured: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Area Under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUCinf) of Radiprodil
Plasma AUCinf of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.
Measured: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Maximum Observed Plasma Concentration (Cmax) of Radiprodil
Plasma Cmax of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.
Measured: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Time to Maximum Observed Plasma Concentration (Tmax) of Radiprodil
Plasma Tmax of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.
Measured: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Time Before First Quantifiable Plasma Concentration (Tlag) of Radiprodil
Plasma Tlag of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.
Measured: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Apparent Total Body Clearance (CL/F) of Radiprodil
Apparent total body clearance of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.
Measured: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Apparent Volume of Distribution Based on the Terminal Phase (Vz/F) of Radiprodil
Apparent volume of distribution of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.
Measured: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Terminal Elimination Half-Life (t½) of Radiprodil
Plasma terminal elimination half-life of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.
Measured: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Secondary outcomes (23)
Area Under the Plasma Concentration-Time Curve from Time 0 to Time of Last Quantifiable Concentration (AUClast) of FBPO
Plasma AUClast of the radiprodil major metabolite FBPO following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants
Measured: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Area Under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUCinf) of FBPO
Plasma AUCinf of FBPO following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.
Measured: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Maximum Observed Plasma Concentration (Cmax) of FBPO
Plasma Cmax of FBPO following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.
Measured: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Time to Maximum Observed Plasma Concentration (Tmax) of FBPO
Plasma Tmax of FBPO following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.
Measured: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Time Before First Quantifiable Plasma Concentration (Tlag) of FBPO
Plasma Tlag of FBPO following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.
Measured: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Terminal Elimination Half-Life (t½) of FBPO
Plasma terminal half-life of FBPO following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.
Measured: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Area Under the Plasma Concentration-Time Curve from Time 0 to Time of Last Quantifiable Concentration (AUClast) of ORR-S
Plasma AUClast of the radiprodil major metabolite ORR-S following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.
Measured: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Area Under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUCinf) of ORR-S
Plasma AUCinf of ORR-S following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.
Measured: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Maximum Observed Plasma Concentration (Cmax) of ORR-S
Plasma Cmax of ORR-S following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.
Measured: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Time to Maximum Observed Plasma Concentration (Tmax) of ORR-S
Plasma Tmax of ORR-S following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.
Measured: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Time Before First Quantifiable Plasma Concentration (Tlag) of ORR-S
Plasma Tlag of ORR-S following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.
Measured: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Terminal Elimination Half-Life (t½) of ORR-S
Plasma terminal half-life of ORR-S following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.
Measured: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Incidence of treatment-emergent adverse events following a single oral dose of radiprodil, summarized by system organ class and preferred term.
Measured: Day 1 through Day 6 (120 hours post-dose)
Number of Participants With Serious Adverse Events (SAEs)
Incidence of serious adverse events following a single oral dose of radiprodil.
Measured: Day 1 through Day 6 (120 hours post-dose)
Number of Participants With Adverse Events Leading to Discontinuation
Incidence of participants who discontinue the study due to an adverse event following a single oral dose of radiprodil.
Measured: Day 1 through Day 6 (120 hours post-dose)
Change From Baseline in Systolic Blood Pressure (mmHg)
Change from baseline in systolic blood pressure following a single oral dose of radiprodil.
Measured: Baseline (Day -1) through Day 6 (120 hours post-dose)
Change From Baseline in Diastolic Blood Pressure (mmHg)
Change from baseline in diastolic blood pressure following a single oral dose of radiprodil.
Measured: Baseline (Day -1) through Day 6 (120 hours post-dose)
Change From Baseline in Heart Rate (beats per minute)
Change from baseline in heart rate following a single oral dose of radiprodil.
Measured: Baseline (Day -1) through Day 6 (120 hours post-dose)
Change From Baseline in Respiratory Rate (breaths per minute)
Change from baseline in respiratory rate following a single oral dose of radiprodil.
Measured: Baseline (Day -1) through Day 6 (120 hours post-dose)
Change From Baseline in Body Temperature (°C)
Change from baseline in body temperature following a single oral dose of radiprodil.
Measured: Baseline (Day -1) through Day 6 (120 hours post-dose)
Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) (milliseconds)
Change from baseline in QT interval corrected using Fridericia's formula (QTcF) following a single oral dose of radiprodil.
Measured: Baseline (Day -1) through Day 6 (120 hours post-dose)
Number of Participants With Clinically Significant Laboratory Abnormalities
Incidence of participants with laboratory values meeting predefined criteria for clinical significance across hematology, serum chemistry, coagulation, and urinalysis following a single oral dose of radiprodil.
Measured: Baseline (Day -1) through Day 6 (120 hours post-dose)
Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) score following a single oral dose of radiprodil.
Measured: Baseline (Day -1) through Day 6 (120 hours post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start3 Mar 2026
- Primary completionMay 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to parallel cohorts based on hepatic function (mild, moderate, or severe hepatic impairment) or healthy status. All participants will receive a single oral dose of radiprodil 15 mg. Healthy participants will be enrolled to match hepatically impaired cohorts by age, sex, and body mass index where feasible. Cohorts will be initiated sequentially following Safety Review Committee review of available safety and pharmacokinetic data, but participants will not cross over between cohorts.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GRIN Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457229
- Sponsor's protocol ID
- RAD-GRIN-505
- Status last verified
- May 2026
- First submitted
- 26 Feb 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-Label Study to Assess the Pharmacokinetics, Safety, and Tolerability of Radiprodil in Hepatically Impaired Participants
- ClinicalTrials.gov ID
- NCT07457229
- Acronym / sponsor ID
- RAD-GRIN-505
- Conditions
- Hepatic Impairment
- Keywords
- Hepatic impairment, Radiprodil
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- GRIN Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 1, open-label, two-arm study designed to assess the pharmacokinetics (PK), safety, and tolerability of a single oral dose of radiprodil in adults with varying degrees of hepatic impairment compared with matched healthy participants.
Up to 40 participants aged 18 to 75 years will be enrolled across five cohorts. Participants will include individuals with mild (Child-Pugh Class A), moderate (Child-Pugh Class B), or severe (Child-Pugh Class C) hepatic impairment, as well as healthy participants matched for age, sex, and body mass index where feasible.
The study consists of a Screening Period (Days -28 to -2), check-in on Day -1, and a Treatment Period. Participants will be confined to the clinical research unit from Day -1 through completion of study assessments on Day 6. On Day 1, all participants will receive a single oral dose of radiprodil 15 mg administered as an oral suspension.
Serial blood samples will be collected to determine plasma concentrations of radiprodil and its major metabolites. Key PK parameters include area under the concentration-time curve (AUC), maximum observed concentration (Cmax), time to maximum concentration (Tmax), terminal half-life (t½), apparent clearance (CL/F), and apparent volume of distribution (Vz/F).
Safety and tolerability will be evaluated throughout the study by monitoring adverse events, vital signs, electrocardiograms, clinical laboratory tests, physical examinations, and Columbia Suicide Severity Rating Scale assessments.
Hepatic impairment can alter the metabolism and exposure of many drugs. Because radiprodil is primarily eliminated via hepatic metabolism, this study is intended to characterize the effect of liver impairment on radiprodil exposure and to inform potential dosing recommendations for future clinical use.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Participants will be assigned to parallel cohorts based on hepatic function (mild, moderate, or severe hepatic impairment) or healthy status. All participants will receive a single oral dose of radiprodil 15 mg. Healthy participants will be enrolled to match hepatically impaired cohorts by age, sex, and body mass index where feasible. Cohorts will be initiated sequentially following Safety Review Committee review of available safety and pharmacokinetic data, but participants will not cross over between cohorts.
| Arm | Type | Receives |
|---|---|---|
| Mild Hepatic Impairment | Experimental | Drug: RadiprodilParticipants with mild hepatic impairment (Child-Pugh Class A). |
| Moderate Hepatic Impairment | Experimental | Drug: RadiprodilParticipants with moderate hepatic impairment (Child-Pugh Class B). |
| Healthy Participants (Matched to Mild/Moderate) | Experimental | Drug: RadiprodilHealthy participants matched to the mild and moderate hepatic impairment cohorts by age, sex, and body mass index where feasible. |
| Severe Hepatic Impairment | Experimental | Drug: RadiprodilParticipants with severe hepatic impairment (Child-Pugh Class C). |
| Healthy Participants (Matched to Severe) | Experimental | Drug: RadiprodilHealthy participants matched to the severe hepatic impairment cohort by age, sex, and body mass index where feasible. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiprodilAlso: RGH-896, Radiprodil oral suspensionRadiprodil will be administered as a single oral dose of 15 mg (2.0 mL of 7.5 mg/mL oral suspension) on Day 1 under fed conditions. Participants will fast overnight for at least 10 hours prior to dosing and consume a standard breakfast approximately 30 minutes before administration. Study drug will be administered with approximately 240 mL of water. All participants across cohorts will receive the same single-dose regimen. | Drug | Healthy Participants (Matched to Mild/Moderate), Healthy Participants (Matched to Severe), Mild Hepatic Impairment, Moderate Hepatic Impairment, Severe Hepatic Impairment |
Primary outcome
Area Under the Plasma Concentration-Time Curve from Time 0 to Time of Last Quantifiable Concentration (AUClast) of Radiprodil
Time frame: Day 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 Radiprodil
Time frame: Day 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 Radiprodil
Time frame: Day 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 Radiprodil
Time frame: Day 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 Radiprodil
Time frame: Day 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 Radiprodil
Time frame: Day 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 Radiprodil
Time frame: Day 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 Radiprodil
Time frame: Day 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.
23 secondary outcomes
Area Under the Plasma Concentration-Time Curve from Time 0 to Time of Last Quantifiable Concentration (AUClast) of FBPO
Time frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Area Under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUCinf) of FBPO
Time frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Maximum Observed Plasma Concentration (Cmax) of FBPO
Time frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Time to Maximum Observed Plasma Concentration (Tmax) of FBPO
Time frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Time Before First Quantifiable Plasma Concentration (Tlag) of FBPO
Time frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Terminal Elimination Half-Life (t½) of FBPO
Time frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Area Under the Plasma Concentration-Time Curve from Time 0 to Time of Last Quantifiable Concentration (AUClast) of ORR-S
Time frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Area Under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUCinf) of ORR-S
Time frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Maximum Observed Plasma Concentration (Cmax) of ORR-S
Time frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Time to Maximum Observed Plasma Concentration (Tmax) of ORR-S
Time frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Time Before First Quantifiable Plasma Concentration (Tlag) of ORR-S
Time frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Terminal Elimination Half-Life (t½) of ORR-S
Time frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day 1 through Day 6 (120 hours post-dose)
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Day 1 through Day 6 (120 hours post-dose)
Number of Participants With Adverse Events Leading to Discontinuation
Time frame: Day 1 through Day 6 (120 hours post-dose)
Change From Baseline in Systolic Blood Pressure (mmHg)
Time frame: Baseline (Day -1) through Day 6 (120 hours post-dose)
Change From Baseline in Diastolic Blood Pressure (mmHg)
Time frame: Baseline (Day -1) through Day 6 (120 hours post-dose)
Change From Baseline in Heart Rate (beats per minute)
Time frame: Baseline (Day -1) through Day 6 (120 hours post-dose)
Change From Baseline in Respiratory Rate (breaths per minute)
Time frame: Baseline (Day -1) through Day 6 (120 hours post-dose)
Change From Baseline in Body Temperature (°C)
Time frame: Baseline (Day -1) through Day 6 (120 hours post-dose)
Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) (milliseconds)
Time frame: Baseline (Day -1) through Day 6 (120 hours post-dose)
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: Baseline (Day -1) through Day 6 (120 hours post-dose)
Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Time frame: Baseline (Day -1) through Day 6 (120 hours post-dose)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
Related trials for Hepatic Impairment
Not yet recruitingPhase 1
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Tacabrutideg (BGB-16673) in Participants With Moderate and Severe Hepatic Impairment
Hepatic Impairment, Healthy Adult Participants
RecruitingPhase 1
A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
Hepatic Impairment
RecruitingPhase 1
A Phase I Study to Investigate the Effect of Hepatic Impairment of AZD9550 and AZD6234
Hepatic Impairment
Not yet recruitingPhase 1
Aleniglipron Hepatic Impairment Study
Hepatic Impairment
Not yet recruitingPhase 1
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Sonrotoclax in Participants With Severe Hepatic Impairment
Hepatic Impairment, Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aneeta Saxena contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Radiprodil in people with Hepatic Impairment, run by GRIN Therapeutics, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Bardell (+1-877-225-0014, ClinicalTrials@GrinTherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Plasma Concentration-Time Curve from Time 0 to Time of Last Quantifiable Concentration (AUClast) of Radiprodil (time frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.