Study to Evaluate the Pharmacokinetics and Safety Effects Following Coadministration of Carbamazepine or Itraconazole With Radiprodil in Healthy Adults

PHASE1RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

May 8, 2025

Primary Completion Date

August 31, 2025

Study Completion Date

September 30, 2025

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

Radiprodil with Carbamazepine

Participants will receive oral doses of Radiprodil in the range of 7.5mg to 30mg along with oral doses of Carbamazepine in the range of 100mg to 300mg twice daily over a period of 27 days.

DRUG

Radiprodil with Itraconazole

Participants will receive oral doses of Radiprodil in the range of 7.5mg to 15mg along with oral doses of Itraconazole 200mg twice daily over a period of 21 days.

Trial Locations (2)

3004

RECRUITING

Nucleus Network Pty Ltd, Melbourne

4006

RECRUITING

Q-Pharm Pty Ltd, Brisbane

Sponsors
All Listed Sponsors
collaborator

Avance Clinical Pty Ltd.

INDUSTRY

lead

GRIN Therapeutics, Inc.

INDUSTRY

NCT06965881 - Study to Evaluate the Pharmacokinetics and Safety Effects Following Coadministration of Carbamazepine or Itraconazole With Radiprodil in Healthy Adults | Biotech Hunter | Biotech Hunter