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New treatment option for Hepatic Impairment
Official title Radiprodil in Participants With Hepatic Impairment
ClinicalTrials.gov ID: NCT07457229
What this study is testing
What is Radiprodil?
Radiprodil is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hepatic impairment.
Also referred to as RGH-896, Radiprodil oral suspension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- 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)...
- 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.
You likely can't join if
- 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.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- DeSoto, Texas, United States
- San Antonio, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include DeSoto, Texas, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.