NCT06975605

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: GRIN Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tuberous Sclerosis Complex (TSC)
• Focal Cortical Dysplasia
• Other Neurological Disorders

Interventions

Type	Name	Description
DRUG	Radiprodil + co-administered drugs	Study drug radiprodil will be administered asbelow in a sequential manner. \- Radiprodil 7.5 mg, 15 mg and 30 mg will be administered in a sequential manner. Co-administered drugs include: - Warfarin - 10 mg tablets, midazolam 1 mg, digoxin 0.25 mg, rosuvastatin 10 mg, omeprazole 20 mg, Vitamin K - 10 mg.

Timeline

• Start date: 2025-05-20
• Primary completion: 2025-07-10
• Completion: 2025-07-10
• First posted: 2025-05-16
• Last updated: 2025-11-18

Locations

1 site across 1 country: Australia