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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

May 20, 2025

Primary Completion Date

July 30, 2025

Study Completion Date

August 30, 2025

Conditions
Tuberous Sclerosis Complex (TSC)Focal Cortical DysplasiaOther Neurological Disorders
Interventions
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."

Trial Locations (1)

3004

Nucleus Network Melbourne, Melbourne

Sponsors
All Listed Sponsors
collaborator

Avance Clinical Pty Ltd.

INDUSTRY

lead

GRIN Therapeutics, Inc.

INDUSTRY

NCT06975605 - Phase 1, Open-label, Drug-drug Interaction Study to Assess Effect Between Radiprodil and the Co-administered Drugs. | Biotech Hunter | Biotech Hunter