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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06965881




Registration number
NCT06965881
Ethics application status
Date submitted
11/04/2025
Date registered
11/05/2025

Titles & IDs
Public title
Study to Evaluate the Pharmacokinetics and Safety Effects Following Coadministration of Carbamazepine or Itraconazole With Radiprodil in Healthy Adults
Scientific title
A Phase 1, Open-label, 2-part Study to Evaluate the Pharmacokinetics and Safety Effects Following Coadministration of a CYP3A4 Inducer (Carbamazepine) or Inhibitor (Itraconazole), With Radiprodil in Healthy Adult Participants
Secondary ID [1] 0 0
RAD-GRIN-504
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tuberous Sclerosis Complex (TSC) 0 0
Focal Cortical Dysplasia 0 0
Other Neurological Disorders 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Radiprodil with Carbamazepine
Treatment: Drugs - Radiprodil with Itraconazole

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

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


Treatment: Drugs: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A: To assess the effect of oral carbamazepine on the maximum observed plasma concentration (Cmax) of oral dosing of radiprodil
Timepoint [1] 0 0
Blood samples will be collected on Days 7 to 10 and 25 to 28.
Primary outcome [2] 0 0
Part B: To assess the effect of oral itraconazole on the maximum plasma concentration (Cmax) of oral dosing of radiprodil
Timepoint [2] 0 0
Blood samples will be collected Days 5 to 9 and 18 to 22.
Primary outcome [3] 0 0
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)
Timepoint [3] 0 0
Blood samples will be collected on Days 7 to 10 and 25 to 28.
Primary outcome [4] 0 0
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)
Timepoint [4] 0 0
Blood samples will be collected Days 5 to 9 and 18 to 22.
Primary outcome [5] 0 0
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
Timepoint [5] 0 0
Blood samples will be collected on Days 7 to 10 and 25 to 28
Primary outcome [6] 0 0
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
Timepoint [6] 0 0
Blood samples will be collected Days 5 to 9 and 18 to 22
Secondary outcome [1] 0 0
Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (SAEs), TEAEs Leading to Discontinuation and Severity of TEAEs
Timepoint [1] 0 0
From Screening to Day 30 and follow up visit 30 days post last dose
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Blood samples for plasma PK will be collected on Days 18 and 25.
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Blood samples for plasma PK will be collected on Days 13 and 18.
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Blood samples for plasma PK will be collected on Days 13 and 18.
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Blood samples for plasma PK will be collected on Days 18 and 25.
Secondary outcome [6] 0 0
Part A: To assess the time to maximum observed plasma concentration (Tmax) of carbamazepine and carbamazepine metabolites following oral dosing of carbamazepine alone and in the presence of radiprodil
Timepoint [6] 0 0
Blood samples for plasma PK will be collected on Days 18 and 25.
Secondary outcome [7] 0 0
Part B: To assess the time to maximum observed plasma concentration (Tmax) of itraconazole following oral dosing of itraconazole alone and in the presence of radiprodil
Timepoint [7] 0 0
Blood samples for plasma PK will be collected on Days 13 and 18.
Secondary outcome [8] 0 0
Part B: To assess the maximum observed plasma concentration (Cmax) of itraconazole following oral dosing of itraconazole alone and in the presence of radiprodil
Timepoint [8] 0 0
Blood samples for plasma PK will be collected on Days 13 and 18.
Secondary outcome [9] 0 0
Part A: To assess the maximum observed plasma concentration (Cmax) of carbamazepine and carbamazepine metabolites following oral dosing of carbamazepine alone and in the presence of radiprodil
Timepoint [9] 0 0
Blood samples for plasma PK will be collected on Days 18 and 25.
Secondary outcome [10] 0 0
Number of participants with abnormal laboratory test results
Timepoint [10] 0 0
From Screening to Day 30 and follow up visit 30 days post last dose
Secondary outcome [11] 0 0
To assess the Columbia-Suicide Severity Rating Scale (C-SSRS) scores
Timepoint [11] 0 0
From Screening to Day 30 and follow up visit 30 days post last dose
Secondary outcome [12] 0 0
12-Lead ECG: Mean change from Baseline to End-of-Treatment in QT interval
Timepoint [12] 0 0
From Screening to Day 30 and follow up visit 30 days post last dose
Secondary outcome [13] 0 0
12-Lead ECG: Mean change from Baseline to End-of-Treatment in PR interval
Timepoint [13] 0 0
From Screening to Day 30 and follow up visit 30 days post last dose
Secondary outcome [14] 0 0
12-Lead ECG: Mean change from Baseline to End-of-Treatment in QRS interval
Timepoint [14] 0 0
From Screening to Day 30 and follow up visit 30 days post last dose

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* 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.

Other inclusion/exclusion eligibility criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
5/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GRIN Therapeutics, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Avance Clinical Pty Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Russell Chin
Address 0 0
GRIN Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Russell Chin
Address 0 0
Country 0 0
Phone 0 0
+1-877-225-0014
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06965881