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

NCT06965881 | Terminated Phase 1

• 1 other identifier: RAD-GRIN-504
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase 1, open-label, 2-part study to evaluate the effect of multiple doses of oral carbamazepine or oral itraconazole on the plasma pharmacokinetic profile of radiprodil in healthy adult participants. In addition, the safety and tolerability of radiprodil given together with oral carbamazepine or itraconazole will be assessed.

Conditions

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

Keywords

healthy adults; tuberous sclerosis; focal cortical dysplasia

Outcome Measures

Primary Outcomes (6)

• Part A: To assess the effect of oral carbamazepine on the maximum observed plasma concentration (Cmax) of oral dosing of radiprodil

  Blood samples will be collected on Days 7 to 10 and 25 to 28.

• Part B: To assess the effect of oral itraconazole on the maximum plasma concentration (Cmax) of oral dosing of radiprodil

  Blood samples will be collected Days 5 to 9 and 18 to 22.

• Part A: To asses the effect of oral carbamazepine on radiprodil area under the plasma concentration-time curve from 0 to last quantifiable concentration (AUClast)

  Blood samples will be collected on Days 7 to 10 and 25 to 28.

• Part B: To asses the effect of oral itraconazole on the radiprodil area under the plasma concentration-time curve from 0 to last quantifiable concentration (AUClast)

  Blood samples will be collected Days 5 to 9 and 18 to 22.

• Part A: To assess the effect of oral oral carbamazepine on the area under the plasma concentration-time curve to the end of dosing interval (AUCtau) of oral dosing of radiprodil

  Blood samples will be collected on Days 7 to 10 and 25 to 28

• Part B: To assess the effect of oral itraconazole on the area under the plasma concentration-time curve to the end of dosing interval (AUCtau) of oral dosing of radiprodil

  Blood samples will be collected Days 5 to 9 and 18 to 22

Secondary Outcomes (14)

• Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (SAEs), TEAEs Leading to Discontinuation and Severity of TEAEs

  From Screening to Day 30 and follow up visit 30 days post last dose

• Part A: To assess the area under the plasma concentration-time curve from 0 to last quantifiable concentration (AUClast) of carbamazepine and carbamazepine metabolites following oral dosing of carbamazepine alone and in the presence of radiprodil

  Blood samples for plasma PK will be collected on Days 18 and 25.

• Part B: To assess the area under the plasma concentration-time curve from 0 to last quantifiable concentration (AUClast) of itraconazole following oral dosing of itraconazole alone and in the presence of radiprodil

  Blood samples for plasma PK will be collected on Days 13 and 18.

• Part B: To assess the area under the plasma concentration-time curve to the end of dosing interval (AUCtau) of itraconazole following oral dosing of itraconazole alone and in the presence of radiprodil

  Blood samples for plasma PK will be collected on Days 13 and 18.

• Part A: To assess the area under the plasma concentration-time curve to the end of dosing interval (AUCtau) of carbamazepine and carbamazepine metabolites following oral dosing of carbamazepine alone and in the presence of radiprodil

  Blood samples for plasma PK will be collected on Days 18 and 25.

Study Arms (2)

Part A: Radiprodil with Carbamazepine

EXPERIMENTAL

Participants will receive multiple oral doses of Radiprodil with Carbamazepine to evaluate the effect that carbamazepine may have on Radiprodil.

Drug: Radiprodil with Carbamazepine

Part B: Radiprodil with Itraconazole

EXPERIMENTAL

Participants will receive multiple oral doses of Radiprodil with Itraconazole to evaluate the effect that itraconazole may have on Radiprodil.

Drug: Radiprodil with Itraconazole

Interventions

Radiprodil with Carbamazepine DRUG

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.

Part A: Radiprodil with Carbamazepine

Radiprodil with Itraconazole DRUG

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.

Part B: Radiprodil with Itraconazole

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female adults between 18 and 55 years of age, inclusive, at Screening
• Body mass index (BMI) between 18 and 32 kg/m2 (inclusive) and weighs at least 50 kg at Screening
• Medically healthy in the opinion of the PI or delegate
• Female participants must be non-lactating and of non-child-bearing potential; or if child-bearing potential must agree to not to attempt to become pregnant or donate ova from signing consent until at least 90 days after the last dose of study drug and must agree to use adequate contraception
• Male participants must agree to not donate sperm from signing consent until at least 90 days after the last dose of study drug and must agree to use adequate contraception
• Have suitable venous access for blood sampling.
• Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions

You may not qualify if:

• Known hypersensitivity to the study drug or any of the study drug ingredients
• Genetic testing positive for HLA genotypes
• Has a history of severe allergic or anaphylactic reaction
• Has history of surgery in the past 90 days prior to Day 1
• Has a history of of risk factors for torsade de pointes or a known arrythmia
• Has a history of or positive serology for HIV, Hepatitis B or Hepatitis C virus at Screening.
• Has a history of suicide attempts or deliberate self-harm
• Use of cannabidiol (CBD) within 30days of Day -1
• Regular consumption of more than 10 standard alcoholic drinks/week and/or more than 4 standard alcoholic drinks on any one day
• Routine consumption of an average of more than five (5) 240 mL servings of coffee or other caffeinated beverages per day
• Use of tobacco-containing products and nicotine or nicotine containing products in the 2 months prior to Day -1
• Women of childbearing potential using oral, injected or implanted hormonal contraception
• Has any other condition or prior therapy that, in the opinion of the Investigator or delegate, may potentially compromise the safety or compliance of the participant, or may preclude the participant from successfully completing the study.

Sponsors & Collaborators

• GRIN Therapeutics, Inc.: lead
• Avance Clinical Pty Ltd.: collaborator

Study Sites (2)

Q-Pharm Pty Ltd

Brisbane, Queensland, 4006, Australia

Location

Nucleus Network Pty Ltd

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Tuberous Sclerosis; Focal Cortical Dysplasia

Interventions

radiprodil; Carbamazepine; Itraconazole

Condition Hierarchy (Ancestors)

Hamartoma; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Nervous System Diseases; Neurocutaneous Syndromes; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Piperazines

Study Officials

• Russell Chin

  GRIN Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: May 11, 2025
• Study Start: May 8, 2025
• Primary Completion: July 8, 2025
• Study Completion: July 8, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)