A Phase 1 interventional study of Radiprodil + co-administered drugs in Tuberous Sclerosis Complex (TSC), Focal Cortical Dysplasia and Other Neurological Disorders, sponsored by GRIN Therapeutics, Inc.. Completed at 1 site in Australia. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by GRIN Therapeutics, Inc. · Phase 1, Interventional, and Treatment
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.
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.
115 studies on the registry are indexed under Tuberous Sclerosis; 27 are open to participants now.
This study's enrollment of 18 is below the median of 52 across 73 interventional studies indexed under Tuberous Sclerosis.
Browse Tuberous Sclerosis studies →GRIN Therapeutics, Inc. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: - Healthy male and female adults between 18 and 55 years of age, inclusive, at Screening.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study Drug - Radiprodil will be administred using a sequential cocktail approach consisting of substrates of multipleCYP enzymes or transporters.
Drug: 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.
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.
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
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
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
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
Time frame: 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
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.
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 5 - pre-dose, 0.5, 1,5, 2, 3, 4, 8, 12, 24 hour Day 19 - 24 hourpost dose
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
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
Safety will be evaluated by: • Incidence, severity and relationship of AEs, serious adverse events (SAEs), AESI, and withdrawals due to AEs
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.
Safety will be evaluated by Incidence, severity and relationship of AEs, serious adverse events (SAEs), AESI, and withdrawals due to AEs
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
Safety will be evaluated by Incidence, severity and relationship of AEs, serious adverse events (SAEs), AESI, and withdrawals due to AEs.
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.
Safety will be evaluated by Incidence, severity and relationship of AEs, serious adverse events (SAEs), AESI, and withdrawals due to AEs.
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
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.
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
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.
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
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.
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
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.
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
Clinical laboratory results assessed using blood and urine samples and will be classified as normal, abnormal not clinically significant (NCS), or abnormal CS.
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.
C-SSRS scores are assessed using the 'baseline-screening' version and the 'since last visit' version at each scheduled time point.
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
C-SSRS scores are assessed using the 'baseline-screening' version and the 'since last visit' version at each scheduled time point.
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.
C-SSRS scores are assessed using the 'baseline-screening' version and the 'since last visit' version at each scheduled time point.
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
C-SSRS scores are assessed using the 'baseline-screening' version and the 'since last visit' version at each scheduled time point.
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
C-SSRS scores are assessed using the 'baseline-screening' version and the 'since last visit' version at each scheduled time point.
Time frame: Day -1,Day 15, Day 24 (End of Study Visit/Early Termination Visit)
Plan to share: No
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Ran from May 2025 to primary completion in Jul 2025, 1 month.
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GRIN Therapeutics, Inc.