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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06975605




Registration number
NCT06975605
Ethics application status
Date submitted
11/04/2025
Date registered
16/05/2025

Titles & IDs
Public title
Phase 1, Open-label, Drug-drug Interaction Study to Assess Effect Between Radiprodil and the Co-administered Drugs.
Scientific title
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
Secondary ID [1] 0 0
RAD-GRIN-506
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 + co-administered drugs

Experimental: Experimental Cohort - Study Drug - Radiprodil will be administred using a sequential cocktail approach consisting of substrates of multipleCYP enzymes or transporters.


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

Outcomes
Primary outcome [1] 0 0
To assess the effect of oral radiprodil on the plasma PK parameter (AUC) of single oral dose of warfarin following repeated oral doses of radiprodil.
Timepoint [1] 0 0
Day1 - Predose, 0.5 hour,1 hour, 1.5, 2, 3, 4, 8, 12 Day 15 - 24 hours post dose, 48 hour, 96, 120, 144 hours
Primary outcome [2] 0 0
To assess the effect of oral radiprodil on the plasma PK parameter (CMax) of single oral dosing of warfarin following repeated oral dosing of radiprodil.
Timepoint [2] 0 0
Blood samples for plasma PK will be collected on the following days. - S-warfin - Day1 - Predose, 0.5 hour,1 hour, 1.5, 2, 3, 4, 8, 12 Day 15 - 24 hours post dose, 48 hour, 96, 120, 144 hours
Primary outcome [3] 0 0
To assess the effect of oral radiprodil on the plasma PK parameter (AUC) of single oral dose of midazolam following repeated oral doses of radiprodil.
Timepoint [3] 0 0
Day 1 - Pre-dose, 0.5, 1, 1.5, 2, 3, 4 , 8, 12, 24 hour day 15- 24 hour post dose -
Primary outcome [4] 0 0
To assess the effect of oral radiprodil on the plasma PK parameter (CMax) of single oral dosing of midazolam following repeated oral dosing of radiprodil
Timepoint [4] 0 0
Day 1 - Pre-dose, 0.5, 1, 1.5, 2, 3, 4 , 8, 12, 24 hour day 15- 24 hour post dose -Digoxin- Day 3- predose, 0.5 hour, 1 , 1.5, 2,3, 4, 8, 12, 24 hour Day 17 - 24 hour post dose.
Primary outcome [5] 0 0
To assess the effect of oral radiprodil on the plasma PK parameter (AUC) of single oral dose of digoxin following repeated oral doses of radiprodil.
Timepoint [5] 0 0
Day 3- predose, 0.5 hour, 1 , 1.5, 2,3, 4, 8, 12, 24 hour Day 17 - 24 hour post dose
Primary outcome [6] 0 0
To assess the effect of oral radiprodil on the plasma PK parameter (CMax) of single oral dosing of digoxin following repeated oral dosing of radiprodil.
Timepoint [6] 0 0
Day 3- predose, 0.5 hour, 1 , 1.5, 2,3, 4, 8, 12, 24 hour Day 17 - 24 hour post dose
Primary outcome [7] 0 0
To assess the effect of oral radiprodil on the plasma PK parameter (AUC) of single oral dose of rosuvastatin following repeated oral doses of radiprodil.
Timepoint [7] 0 0
Day 3 - pre-dose, 0.5, 1,5, 2, 3, 4, 8, 12, 24 hour Day 17 - 24 hour post dose
Primary outcome [8] 0 0
To assess the effect of oral radiprodil on the plasma PK parameter (CMax) of single oral dosing of rosuvastatin following repeated oral dosing of radiprodil
Timepoint [8] 0 0
Day 3 - pre-dose, 0.5, 1,5, 2, 3, 4, 8, 12, 24 hour Day 17 - 24 hour post dose
Primary outcome [9] 0 0
To assess the effect of oral radiprodil on the plasma PK parameter (AUC) of single oral dose of omeprazole following repeated oral doses of radiprodil.
Timepoint [9] 0 0
Day 5 - pre-dose, 0.5, 1,5, 2, 3, 4, 8, 12, 24 hour Day 19 - 24 hourpost dose
Primary outcome [10] 0 0
To assess the effect of oral radiprodil on the plasma PK parameter (CMax) of single oral dosing of omeprazole following repeated oral dosing of radiprodil.
Timepoint [10] 0 0
Day 5 - pre-dose, 0.5, 1,5, 2, 3, 4, 8, 12, 24 hour Day 19 - 24 hourpost dose
Secondary outcome [1] 0 0
To assess the safety of oral dosing of radiprodil co-administered with midazolam.
Timepoint [1] 0 0
Adverse events: will be assessed throughout the study period from Day -1 untill Day 24 (End of StudyVisit/Early Termination Visit) and Follow up (Telephone call) which is 30 days post last dose.
Secondary outcome [2] 0 0
To assess the safety of oral dosing of radiprodil co-administered with digoxin
Timepoint [2] 0 0
Adverse events: will be assessed throughout the study period from Day -1 untill Day 24 (End of StudyVisit/Early Termination Visit) and Follow up (Telephone call) which is 30 days post last dose
Secondary outcome [3] 0 0
To assess the safety of oral dosing of radiprodil co-administered with rosuvastatin.
Timepoint [3] 0 0
Adverse events: will be assessed throughout the study period from Day -1 untill Day 24 (End of StudyVisit/Early Termination Visit) and Follow up (Telephone call) which is 30 days post last dose
Secondary outcome [4] 0 0
To assess the safety of oral dosing of radiprodil co-administered with omeprazole
Timepoint [4] 0 0
Adverse events: will be assessed throughout the study period from Day -1 untill Day 24 (End of StudyVisit/Early Termination Visit) and Follow up (Telephone call) which is 30 days post last dose.
Secondary outcome [5] 0 0
To assess the safety of oral dosing of radiprodil co-administered with oral warfarin.
Timepoint [5] 0 0
Adverse events: will be assessed throughout the study period from Day -1 untill Day 24 (End of StudyVisit/Early Termination Visit) and Follow up (Telephone call) which is 30 days post last dose.
Secondary outcome [6] 0 0
12-lead ECG - Mean change in QT interval from baseline to end of treatment (oral dosing of radiprodil co-administered with midazolam)
Timepoint [6] 0 0
12 lead ECG- Screening, Day -1, Day 1, Day 3, Day 5, Day 7-8, 9-10, 11-14, 15, 17, 19 and Day 24 (End of Study Visit/Early Termination Visit)
Secondary outcome [7] 0 0
12-lead ECG - Mean change in QT interval from baseline to end of treatment (oral radiprodil co-administered with digoxin)
Timepoint [7] 0 0
12 lead ECG- Screening, Day -1, Day 1, Day 3, Day 5, Day 7-8, 9-10, 11-14, 15, 17, 19 and Day 24 (End of Study Visit/Early Termination Visit)
Secondary outcome [8] 0 0
12-lead ECG- Mean change from Baseline to End-of-Treatment in QT interval(oral dosing of radiprodil co-administered with rosuvastatin)
Timepoint [8] 0 0
12 lead ECG- Screening, Day -1, Day 1, Day 3, Day 5, Day 7-8, 9-10, 11-14, 15, 17, 19 and Day 24 (End of Study Visit/Early Termination Visit)
Secondary outcome [9] 0 0
12-lead ECG- Mean change from Baseline to End-of-Treatment in QT interval (oral dosing of radiprodil co-administered with omeprazole)
Timepoint [9] 0 0
12 lead ECG- Screening, Day -1, Day 1, Day 3, Day 5, Day 7-8, 9-10, 11-14, 15, 17, 19 and Day 24 (End of Study Visit/Early Termination Visit)
Secondary outcome [10] 0 0
To assess the safety of oral dosing of radiprodil co-administered with oral warfarin
Timepoint [10] 0 0
Clinical lab parameters- Screening, Day -1, Days 2-4, Days 6-14,Days 16-18, Days 20-21 and Day 24 (End of Study Visit/Early Termination Visit)
Secondary outcome [11] 0 0
To assess the safety of oral dosing of radiprodil co-administered with midazolam
Timepoint [11] 0 0
Clinical lab parameters- Screening, Day -1, Days 2-4, Days 6-14,Days 16-18, Days 20-21 and Day 24 (End of Study Visit/Early Termination Visit)
Secondary outcome [12] 0 0
To assess the safety of oral dosing of radiprodil co-administered with digoxin
Timepoint [12] 0 0
Clinical lab parameters- Screening, Day -1, Days 2-4, Days 6-14,Days 16-18, Days 20-21 and Day 24 (End of Study Visit/Early Termination Visit)
Secondary outcome [13] 0 0
To assess the safety of oral dosing of radiprodil co-administered with rosuvastatin
Timepoint [13] 0 0
Clinical lab parameters- Screening, Day -1, Days 2-4, Days 6-14,Days 16-18, Days 20-21 and Day 24 (End of Study Visit/Early Termination Visit)
Secondary outcome [14] 0 0
To assess the safety of oral dosing of radiprodil co-administered with omeprazole
Timepoint [14] 0 0
Clinical lab parameters- Screening, Day -1, Days 2-4, Days 6-14,Days 16-18, Days 20-21 and Day 24 (End of Study Visit/EarlyTermination Visit)
Secondary outcome [15] 0 0
To assess the safety of oral dosing of radiprodil co-administered with oral warfarin.
Timepoint [15] 0 0
Day -1,Day 15, Day 24 (End of Study Visit/Early Termination Visit)
Secondary outcome [16] 0 0
To assess the safety of oral dosing of radiprodil co-administered with midazolam
Timepoint [16] 0 0
Day -1,Day 15, Day 24 (End of Study Visit/Early Termination Visit)
Secondary outcome [17] 0 0
To assess the safety of oral dosing of radiprodil co-administered with digoxin.
Timepoint [17] 0 0
Day -1,Day 15, Day 24 (End of Study Visit/Early Termination Visit)
Secondary outcome [18] 0 0
To assess the safety of oral dosing of radiprodil co-administered with rosuvastatin
Timepoint [18] 0 0
Day -1,Day 15, Day 24 (End of Study Visit/Early Termination Visit)
Secondary outcome [19] 0 0
To assess the safety of oral dosing of radiprodil co-administered with omeprazole
Timepoint [19] 0 0
Day -1,Day 15, Day 24 (End of Study Visit/Early Termination Visit)

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.
* Female participants must be non-lactating and of non-child-bearing potential.
* Male participants if engaging in sexual intercourse with a female partner who could become pregnant must agree to use adequate contraception.
* Participant is of Caucasian origin (note: people of Filipino, Chinese, Japanese, Korean, Vietnamese or Asian-Indian origin are excluded due to higher exposure following rosuvastatin administration).
* Ability to provide signed informed consent and to understand and comply with the requirements of the study including dietary requirements and requirement to stay confined on site for the duration of the study
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* History of contraindications or hypersensitivity to radiprodil or any components of the formulations or history of hypersensitivity to warfarin, midazolam, digoxin, rosuvastatin, omeprazole, or vitamin K.
* Female participants who are pregnant, breastfeeding, or have a positive pregnancy test at Screening.
* History or presence of significant (in the opinion of the PI) cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, urologic, neurological, malignancy, psychiatric disease, or brain surgery or injury.
* Any surgical or medical condition that, in the opinion of the PI, could interfere with the absorption, distribution, metabolism, or excretion of the drug.
* History of any CS allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic seasonal allergies at time of dosing on Day 1).
* History of illicit drug abuse or alcohol abuse use within 2 years of Screening.
* History of suicide attempts or deliberate self-harm, or a score of 4 or 5 on ideation or any suicidal behavior on the C-SSRS.
* Routine consumption of more than 2 units of alcoholic beverages per day or more than 14 units per week (a unit of alcohol is equivalent to 1 can of beer, 1 glass of wine, or the equivalent of 1 alcoholic drink).
* Routine consumption of an average of more than five (5) 240 mL servings of coffee or other caffeinated beverages per day.
* A positive test result for amphetamines, barbiturates, benzodiazepines, cocaine, methadone, methamphetamines, opiates, methylenedioxymethamphetamine, phencyclidine, tetrahydrocannabinol, cotinine, or alcohol at Screening or Day -1.
* Use of marijuana (including prescribed marijuana) within 30 days of Day -1.
* Use of tobacco-containing products and nicotine or nicotine containing products in the 2 months prior to Day 1.
* Use of any IP and prescription drug within 30 days of Day -1 or within 5 half-lives whichever is longer.
* Use of any over-the-counter (OTC) medication, including herbal products within the 14 days or 5 half-lives prior to dosing, whichever is longer.
* Any vaccine within 7 days of Day -1.
* Acute illness within 14 days of study Day 1.
* Surgery within the past 90 days prior to Day 1.
* Any CS ECG abnormality at Screening.
* Received an IP in any clinical trial within 30 days of Day -1.
* Women of childbearing potential using oral, injected or implanted hormonal contraception.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Other
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
20/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/08/2025
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Melbourne - 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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ofer Gonen, Doctor
Address 0 0
Country 0 0
Phone 0 0
+61 1800243733
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/NCT06975605