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Phase 1, Open-label, Drug-drug Interaction Study to Assess Effect Between Radiprodil and the Co-administered Drugs. | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Phase 1, Open-label, Drug-drug Interaction Study to Assess Effect Between Radiprodil and the Co-administered Drugs.

Phase 1, Open-label, 3-period Study to Evaluate Drug-Drug Interaction Potential of Radiprodil With Cocktail Probes Representative of CYP3A4, CYP2C9, CYP2C19, P-gp and BCRP in Healthy Adult Subjects

NCT06975605•GRIN Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

This is a Phase 1, open-label, 3-period study to determine radiprodil's potential to act as a perpetrator of cytochrome P-450 (CYP) metabolic pathways and transporter pathways. The study will evaluate the pharmacokinetics (PK) and safety effects of co-administration of radiprodil with oral midazolam, rosuvastatin, warfarin, digoxin, and omeprazole in healthy adult subjects. The study will be conducted in 1 cohort of healthy adult participants only.

Detailed Description

This is a Phase 1, open-label, 3-period study to evaluate the PK and safety effects of co-administration of radiprodil with oral midazolam, rosuvastatin, warfarin, digoxin, and omeprazole in healthy adult subjects. The study will be conducted at a single site. The study will be conducted in 1 cohort of participantsUp to 18 male or female healthy adults are planned to be recruited in this study. Participants will be required to be in the study for up to 80 days, which includes a 27-day screening period, 24-day confinement period, and a follow-up phone call 30 days (± 2 days) after the last dose of study drug. Study drugs will be administered using a sequential cocktail approach consisting of substrates of multiple CYP enzymes or transporters.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Body mass index (BMI) between 18 and 32 kg/m2 (inclusive) and weighs at least 50 kg at Screening.
•Female participants must be non-lactating and of non-child-bearing potential.
•Male participants if engaging in sexual intercourse with a female partner who could become pregnant must agree to use adequate contraception.
•Participant is of Caucasian origin (note: people of Filipino, Chinese, Japanese, Korean, Vietnamese or Asian-Indian origin are excluded due to higher exposure following rosuvastatin administration).
•Ability to provide signed informed consent and to understand and comply with the requirements of the study including dietary requirements and requirement to stay confined on site for the duration of the study

Exclusion Criteria

•History of contraindications or hypersensitivity to radiprodil or any components of the formulations or history of hypersensitivity to warfarin, midazolam, digoxin, rosuvastatin, omeprazole, or vitamin K.
•Female participants who are pregnant, breastfeeding, or have a positive pregnancy test at Screening.
•History or presence of significant (in the opinion of the PI) cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, urologic, neurological, malignancy, psychiatric disease, or brain surgery or injury.
•Any surgical or medical condition that, in the opinion of the PI, could interfere with the absorption, distribution, metabolism, or excretion of the drug.
•History of any CS allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic seasonal allergies at time of dosing on Day 1).
•History of illicit drug abuse or alcohol abuse use within 2 years of Screening.
•History of suicide attempts or deliberate self-harm, or a score of 4 or 5 on ideation or any suicidal behavior on the C-SSRS.
•Routine consumption of more than 2 units of alcoholic beverages per day or more than 14 units per week (a unit of alcohol is equivalent to 1 can of beer, 1 glass of wine, or the equivalent of 1 alcoholic drink).
•Routine consumption of an average of more than five (5) 240 mL servings of coffee or other caffeinated beverages per day.
•A positive test result for amphetamines, barbiturates, benzodiazepines, cocaine, methadone, methamphetamines, opiates, methylenedioxymethamphetamine, phencyclidine, tetrahydrocannabinol, cotinine, or alcohol at Screening or Day -1.
+10 more criteria

Locations (1)

Nucleus Network Melbourne

Melbourne, Victoria, Australia

Key Dates

Start Date

May 20, 2025

Primary Completion Date

July 10, 2025

Completion Date

July 10, 2025

Last Updated

November 18, 2025

Enrollment

ACTUAL participants

Conditions

Tuberous Sclerosis Complex (TSC)Focal Cortical DysplasiaOther Neurological Disorders

Interventions

Radiprodil + co-administered drugs

DRUG

TANDem-2: Closing the Gap to Interventions for TAND

NCT06879665

Adult Caregivers of Individuals With TSCTuberous Sclerosis Complex (TSC)

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NCT04836715

Parkinson DiseaseOther Neurological Disorders+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Phase 1, Open-label, Drug-drug Interaction Study to Assess Effect Between Radiprodil and the Co-administered Drugs.

Inclusion Criteria

Exclusion Criteria

TANDem-2: Closing the Gap to Interventions for TAND

Prevalence of Visual Dysfunction in Neurological Disorders

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