Radiprodil in Participants With Hepatic Impairment
ConditionHepatic Impairment
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGRIN Therapeutics, Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Radiprodil
DrugRadiprodil 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.
Treatment groups
40 Participants
are divided into 5 treatment groupsGroup A: Mild Hepatic ImpairmentExperimental treatment 1 intervention
Group B: Moderate Hepatic ImpairmentExperimental treatment 1 intervention
Group C: Healthy Participants (Matched to Mild/Moderate)Experimental treatment 1 intervention
Group D: Severe Hepatic ImpairmentExperimental treatment 1 intervention
Group E: Healthy Participants (Matched to Severe)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Day 1 (pre-dose) through Day 6 (120 hours post-dose)2
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.
Time frame
Day 1 (pre-dose) through Day 6 (120 hours post-dose)3
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.
Time frame
Day 1 (pre-dose) through Day 6 (120 hours post-dose)4
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.
Time frame
Day 1 (pre-dose) through Day 6 (120 hours post-dose)Secondary outcomes
1
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
Time frame
Day 1 (pre-dose) through Day 6 (120 hours post-dose)2
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.
Time frame
Day 1 (pre-dose) through Day 6 (120 hours post-dose)3
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.
Time frame
Day 1 (pre-dose) through Day 6 (120 hours post-dose)4
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.
Time frame
Day 1 (pre-dose) through Day 6 (120 hours post-dose)Sponsors and contacts
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Source ClinicalTrials.gov