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NCT07457229 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Open-Label Study of Radiprodil Pharmacokinetics, Safety, and Tolerability in Hepatically Impaired Participants
A Phase 1 study of Hepatic Impairment, sponsored by GRIN Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 2
- Study locations
NCT07457229: Recruiting Phase 1 study of Hepatic Impairment, sponsored by GRIN Therapeutics.
NCT07457229 is a Phase 1 study of Hepatic Impairment that is actively recruiting participants, run by GRIN Therapeutics. The registered enrollment target is 40 participants, above the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (11% higher). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07457229, a Phase 1 study of Hepatic Impairment, is actively recruiting participants, sponsored by GRIN Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 2
- Study locations
Study 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. 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.
Primary Outcome
Plasma AUClast of radiprodil following a single oral dose in participants with varying degrees of hepatic impairment and healthy participants.
Conditions Studied
Interventions
- DRUG Radiprodil
Study Locations (2)
Texas
- Epic Medical Research - DeSoto
- Texas Liver Institute - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2026-03-03 |
| Est. Completion | 2027-08 |
| Phase | Phase 1 |
What NCT07457229 shows while recruiting
NCT07457229 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, above the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (11% higher).
The record links to 1 condition, with Hepatic Impairment appearing as the primary indexed condition, and to 1 intervention - of which Radiprodil is the first listed.
NCT07457229 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT07457229 about?
NCT07457229 is a clinical study titled "Phase 1 Open-Label Study of Radiprodil Pharmacokinetics, Safety, and Tolerability 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 neurod...
What is the current status of trial NCT07457229?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2026-03-03. Estimated completion is 2027-08.
What conditions does trial NCT07457229 study?
This clinical trial studies the following conditions: Hepatic Impairment.
What interventions are being tested in trial NCT07457229?
The interventions under investigation include: Radiprodil (DRUG).
Who is sponsoring clinical trial NCT07457229?
This trial is sponsored by GRIN Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07457229 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatic Impairment
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07457229's enrollment target sits among peer trials
40 8th of 48 higher than 41 of 48 other Hepatic Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatic Impairment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)
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