Tuberous Sclerosis Complex (TSC)Phase 1NCT06975605
Phase 1, Open-label, Drug-drug Interaction Study to Assess Effect Between Radiprodil and the Co-administered Drugs.
A Phase 1 study testing Radiprodil + co-administered drugs in people with Tuberous Sclerosis Complex (TSC) and Focal Cortical Dysplasia, run by GRIN Therapeutics, Inc. at 1 site in Australia.
Trial summary
This is a Phase 1, open-label, 3-period study to determine radiprodil's potential to act as a perpetrator of cytochrome P-450 (CYP) metabolic pathways and transporter pathways. The study will evaluate the pharmacokinetics (PK) and safety effects of co-administration of radiprodil with oral midazolam, rosuvastatin… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberous Sclerosis Complex (TSC), Focal Cortical Dysplasia, Other Neurological Disorders
- What is being tested?
- Radiprodil + co-administered drugs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteAustralia
- Study dates
- 20 May 2025to 10 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
This is a Phase 1, open-label, 3-period study to determine radiprodil's potential to act as a perpetrator of cytochrome P-450 (CYP) metabolic pathways and transporter pathways. The study will evaluate the pharmacokinetics (PK) and safety effects of co-administration of radiprodil with oral midazolam, rosuvastatin, warfarin, digoxin, and omeprazole in healthy adult subjects. The study will be conducted in 1 cohort of healthy adult participants only.
Read the detailed description
This is a Phase 1, open-label, 3-period study to evaluate the PK and safety effects of co-administration of radiprodil with oral midazolam, rosuvastatin, warfarin, digoxin, and omeprazole in healthy adult subjects. The study will be conducted at a single site.
The study will be conducted in 1 cohort of participantsUp to 18 male or female healthy adults are planned to be recruited in this study. Participants will be required to be in the study for up to 80 days, which includes a 27-day screening period, 24-day confinement period, and a follow-up phone call 30 days (± 2 days) after the last dose of study drug. Study drugs will be administered using a sequential cocktail approach consisting of substrates of multiple CYP enzymes or transporters.
- Being tested
- Radiprodil + co-administered drugs
- Keywords
- healthy adults, tuberous sclerosis, focal cortical dysplasia
- Medical subject headings
- Tuberous Sclerosis, Focal Cortical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiprodil + co-administered drugsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Cohort | Experimental | Study Drug - Radiprodil will be administred using a sequential cocktail approach consisting of substrates of multipleCYP enzymes or transporters. Receives: Drug: Radiprodil + co-administered drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Blood samples will be assessed.
Measured: 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
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.
Blood plasma samples will be assessed
Measured: 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
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.
Blood plasma samples will be assessed
Measured: Day 1 - Pre-dose, 0.5, 1, 1.5, 2, 3, 4 , 8, 12, 24 hour day 15- 24 hour post dose -
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
Blood plasma samples will be assessed
Measured: 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.
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.
Blood plasma samples will be assessed
Measured: Day 3- predose, 0.5 hour, 1 , 1.5, 2,3, 4, 8, 12, 24 hour Day 17 - 24 hour post dose
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.
Blood plasma samples will be assessed
Measured: Day 3- predose, 0.5 hour, 1 , 1.5, 2,3, 4, 8, 12, 24 hour Day 17 - 24 hour post dose
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.
Blood plasma samples will be assessed
Measured: Day 3 - pre-dose, 0.5, 1,5, 2, 3, 4, 8, 12, 24 hour Day 17 - 24 hour post dose
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
Blood plasma samples will be assessed
Measured: Day 3 - pre-dose, 0.5, 1,5, 2, 3, 4, 8, 12, 24 hour Day 17 - 24 hour post dose
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.
Blood plasma samples will be assessed
Measured: Day 5 - pre-dose, 0.5, 1,5, 2, 3, 4, 8, 12, 24 hour Day 19 - 24 hourpost dose
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.
Blood plasma samples will be assessed
Measured: Day 5 - pre-dose, 0.5, 1,5, 2, 3, 4, 8, 12, 24 hour Day 19 - 24 hourpost dose
Secondary outcomes (19)
To assess the safety of oral dosing of radiprodil co-administered with midazolam.
Safety will be evaluated by: Incidence, severity and relationship of AEs, serious adverse events (SAEs), AESI, and withdrawals due to AEs
Measured: 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.
To assess the safety of oral dosing of radiprodil co-administered with digoxin
Safety will be evaluated by: • Incidence, severity and relationship of AEs, serious adverse events (SAEs), AESI, and withdrawals due to AEs
Measured: 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
To assess the safety of oral dosing of radiprodil co-administered with rosuvastatin.
Safety will be evaluated by Incidence, severity and relationship of AEs, serious adverse events (SAEs), AESI, and withdrawals due to AEs
Measured: 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
To assess the safety of oral dosing of radiprodil co-administered with omeprazole
Safety will be evaluated by Incidence, severity and relationship of AEs, serious adverse events (SAEs), AESI, and withdrawals due to AEs.
Measured: 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.
To assess the safety of oral dosing of radiprodil co-administered with oral warfarin.
Safety will be evaluated by Incidence, severity and relationship of AEs, serious adverse events (SAEs), AESI, and withdrawals due to AEs.
Measured: 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.
12-lead ECG - Mean change in QT interval from baseline to end of treatment (oral dosing of radiprodil co-administered with midazolam)
Measured: 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)
12-lead ECG - Mean change in QT interval from baseline to end of treatment (oral radiprodil co-administered with digoxin)
Measured: 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)
12-lead ECG- Mean change from Baseline to End-of-Treatment in QT interval(oral dosing of radiprodil co-administered with rosuvastatin)
Measured: 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)
12-lead ECG- Mean change from Baseline to End-of-Treatment in QT interval (oral dosing of radiprodil co-administered with omeprazole)
Measured: 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)
To assess the safety of oral dosing of radiprodil co-administered with oral warfarin
Change from baseline in clinical laboratory parameters(hematology, coagulation, clinical chemistry, and urinalysis). Clinical laboratory results assessed using blood and urine samples and will be classified as normal, abnormal not clinically significant (NCS), or abnormal CS.
Measured: 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)
To assess the safety of oral dosing of radiprodil co-administered with midazolam
Change from baseline in clinical laboratory parameters(hematology, coagulation, clinical chemistry, and urinalysis). Clinical laboratory results assessed using blood and urine samples and will be classified as normal, abnormal not clinically significant (NCS), or abnormal CS.
Measured: 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)
To assess the safety of oral dosing of radiprodil co-administered with digoxin
Change from baseline in clinical laboratory parameters(hematology, coagulation, clinical chemistry, and urinalysis). Clinical laboratory results assessed using blood and urine samples and will be classified as normal, abnormal not clinically significant (NCS), or abnormal CS.
Measured: 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)
To assess the safety of oral dosing of radiprodil co-administered with rosuvastatin
Change from baseline in clinical laboratory parameters(hematology, coagulation, clinical chemistry, and urinalysis). Clinical laboratory results assessed using blood and urine samples and will be classified as normal, abnormal not clinically significant (NCS), or abnormal CS.
Measured: 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)
To assess the safety of oral dosing of radiprodil co-administered with omeprazole
Clinical laboratory results assessed using blood and urine samples and will be classified as normal, abnormal not clinically significant (NCS), or abnormal CS.
Measured: 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)
To assess the safety of oral dosing of radiprodil co-administered with oral warfarin.
C-SSRS scores are assessed using the 'baseline-screening' version and the 'since last visit' version at each scheduled time point.
Measured: Day -1,Day 15, Day 24 (End of Study Visit/Early Termination Visit)
To assess the safety of oral dosing of radiprodil co-administered with midazolam
C-SSRS scores are assessed using the 'baseline-screening' version and the 'since last visit' version at each scheduled time point.
Measured: Day -1,Day 15, Day 24 (End of Study Visit/Early Termination Visit)
To assess the safety of oral dosing of radiprodil co-administered with digoxin.
C-SSRS scores are assessed using the 'baseline-screening' version and the 'since last visit' version at each scheduled time point.
Measured: Day -1,Day 15, Day 24 (End of Study Visit/Early Termination Visit)
To assess the safety of oral dosing of radiprodil co-administered with rosuvastatin
C-SSRS scores are assessed using the 'baseline-screening' version and the 'since last visit' version at each scheduled time point.
Measured: Day -1,Day 15, Day 24 (End of Study Visit/Early Termination Visit)
To assess the safety of oral dosing of radiprodil co-administered with omeprazole
C-SSRS scores are assessed using the 'baseline-screening' version and the 'since last visit' version at each scheduled time point.
Measured: Day -1,Day 15, Day 24 (End of Study Visit/Early Termination Visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start20 May 2025
- Primary completion10 Jul 2025
- Study completion10 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberous Sclerosis Complex (TSC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Study drugs will be administered using a sequential cocktail approach consisting of substrates of multipleCYP enzymes or transporters.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- GRIN Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avance Clinical Pty Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975605
- Sponsor's protocol ID
- RAD-GRIN-506
- Status last verified
- Nov 2025
- First submitted
- 11 Apr 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06975605
- Acronym / sponsor ID
- RAD-GRIN-506
- Keywords
- healthy adults, tuberous sclerosis, focal cortical dysplasia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- GRIN Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Avance Clinical Pty Ltd.
- Study start
- 20 May 2025 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, open-label, 3-period study to determine radiprodil's potential to act as a perpetrator of cytochrome P-450 (CYP) metabolic pathways and transporter pathways. The study will evaluate the pharmacokinetics (PK) and safety effects of co-administration of radiprodil with oral midazolam, rosuvastatin, warfarin, digoxin, and omeprazole in healthy adult subjects. The study will be conducted in 1 cohort of healthy adult participants only.
Detailed description
This is a Phase 1, open-label, 3-period study to evaluate the PK and safety effects of co-administration of radiprodil with oral midazolam, rosuvastatin, warfarin, digoxin, and omeprazole in healthy adult subjects. The study will be conducted at a single site.
The study will be conducted in 1 cohort of participantsUp to 18 male or female healthy adults are planned to be recruited in this study. Participants will be required to be in the study for up to 80 days, which includes a 27-day screening period, 24-day confinement period, and a follow-up phone call 30 days (± 2 days) after the last dose of study drug. Study drugs will be administered using a sequential cocktail approach consisting of substrates of multiple CYP enzymes or transporters.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study drugs will be administered using a sequential cocktail approach consisting of substrates of multipleCYP enzymes or transporters.
| Arm | Type | Receives |
|---|---|---|
| Experimental Cohort | Experimental | Drug: Radiprodil + co-administered drugsStudy Drug - Radiprodil will be administred using a sequential cocktail approach consisting of substrates of multipleCYP enzymes or transporters. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (20 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiprodil + co-administered drugsStudy 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. | Drug | Experimental Cohort |
Primary outcome
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.
Time frame: 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
Blood samples will be assessed.
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.
Time frame: 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
Blood plasma samples will be assessed
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.
Time frame: Day 1 - Pre-dose, 0.5, 1, 1.5, 2, 3, 4 , 8, 12, 24 hour day 15- 24 hour post dose -
Blood plasma samples will be assessed
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
Time frame: 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.
Blood plasma samples will be assessed
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.
Time frame: Day 3- predose, 0.5 hour, 1 , 1.5, 2,3, 4, 8, 12, 24 hour Day 17 - 24 hour post dose
Blood plasma samples will be assessed
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.
Time frame: Day 3- predose, 0.5 hour, 1 , 1.5, 2,3, 4, 8, 12, 24 hour Day 17 - 24 hour post dose
Blood plasma samples will be assessed
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.
Time frame: Day 3 - pre-dose, 0.5, 1,5, 2, 3, 4, 8, 12, 24 hour Day 17 - 24 hour post dose
Blood plasma samples will be assessed
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
Time frame: Day 3 - pre-dose, 0.5, 1,5, 2, 3, 4, 8, 12, 24 hour Day 17 - 24 hour post dose
Blood plasma samples will be assessed
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.
Time frame: Day 5 - pre-dose, 0.5, 1,5, 2, 3, 4, 8, 12, 24 hour Day 19 - 24 hourpost dose
Blood plasma samples will be assessed
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.
Time frame: Day 5 - pre-dose, 0.5, 1,5, 2, 3, 4, 8, 12, 24 hour Day 19 - 24 hourpost dose
Blood plasma samples will be assessed
19 secondary outcomes
To assess the safety of oral dosing of radiprodil co-administered with midazolam.
Time frame: 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.
To assess the safety of oral dosing of radiprodil co-administered with digoxin
Time frame: 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
To assess the safety of oral dosing of radiprodil co-administered with rosuvastatin.
Time frame: 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
To assess the safety of oral dosing of radiprodil co-administered with omeprazole
Time frame: 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.
To assess the safety of oral dosing of radiprodil co-administered with oral warfarin.
Time frame: 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.
12-lead ECG - Mean change in QT interval from baseline to end of treatment (oral dosing of radiprodil co-administered with midazolam)
Time frame: 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)
12-lead ECG - Mean change in QT interval from baseline to end of treatment (oral radiprodil co-administered with digoxin)
Time frame: 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)
12-lead ECG- Mean change from Baseline to End-of-Treatment in QT interval(oral dosing of radiprodil co-administered with rosuvastatin)
Time frame: 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)
12-lead ECG- Mean change from Baseline to End-of-Treatment in QT interval (oral dosing of radiprodil co-administered with omeprazole)
Time frame: 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)
To assess the safety of oral dosing of radiprodil co-administered with oral warfarin
Time frame: 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)
To assess the safety of oral dosing of radiprodil co-administered with midazolam
Time frame: 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)
To assess the safety of oral dosing of radiprodil co-administered with digoxin
Time frame: 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)
To assess the safety of oral dosing of radiprodil co-administered with rosuvastatin
Time frame: 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)
To assess the safety of oral dosing of radiprodil co-administered with omeprazole
Time frame: 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)
To assess the safety of oral dosing of radiprodil co-administered with oral warfarin.
Time frame: Day -1,Day 15, Day 24 (End of Study Visit/Early Termination Visit)
To assess the safety of oral dosing of radiprodil co-administered with midazolam
Time frame: Day -1,Day 15, Day 24 (End of Study Visit/Early Termination Visit)
To assess the safety of oral dosing of radiprodil co-administered with digoxin.
Time frame: Day -1,Day 15, Day 24 (End of Study Visit/Early Termination Visit)
To assess the safety of oral dosing of radiprodil co-administered with rosuvastatin
Time frame: Day -1,Day 15, Day 24 (End of Study Visit/Early Termination Visit)
To assess the safety of oral dosing of radiprodil co-administered with omeprazole
Time frame: Day -1,Day 15, Day 24 (End of Study Visit/Early Termination Visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Radiprodil + co-administered drugs in people with Tuberous Sclerosis Complex (TSC) and Focal Cortical Dysplasia, run by GRIN Therapeutics, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.