Tuberous Sclerosis Complex (TSC)Phase 1NCT06965881
Study to Evaluate the Pharmacokinetics and Safety Effects Following Coadministration of Carbamazepine or Itraconazole With Radiprodil in Healthy Adults
A Phase 1 study testing Radiprodil with Carbamazepine and Radiprodil with Itraconazole in people with Tuberous Sclerosis Complex (TSC) and Focal Cortical Dysplasia, run by GRIN Therapeutics, Inc. at 2 sites in Australia.
Trial 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. 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 with Carbamazepine and Radiprodil with Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesAustralia
- Study dates
- 8 May 2025to 8 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
- 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
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Q-Pharm Pty Ltd
Brisbane, Queensland, 4006
Nucleus Network Pty Ltd
Melbourne, Victoria, 3004
About this study
Official 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
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.
Read the detailed description
This is an open label study conducted in healthy adult volunteers. The study will be conducted in 2 parallel parts. A total of 36 participants will be enrolled in the study (N=18 per Part).
Part A: will enrol 18 participants to receive multiple oral doses of the radiprodil in the range of 7.5mg to 30mg with oral carbamazepine.
Part B: will enrol 18 participants to receive multiple oral doses of radiprodil in the range of 7.5mg to 15mg with oral itraconazole.
- Being tested
- Radiprodil with Carbamazepine, Radiprodil with Itraconazole
- 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 with CarbamazepineDrug
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.
Radiprodil with ItraconazoleDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Radiprodil with Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: To assess the effect of oral carbamazepine on the maximum observed plasma concentration (Cmax) of oral dosing of radiprodil
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Frequency, type, severity and duration of adverse events, serious adverse events and adverse drug reactions.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Blood samples for plasma PK will be collected on Days 18 and 25.
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
Measured: Blood samples for plasma PK will be collected on Days 18 and 25.
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
Measured: Blood samples for plasma PK will be collected on Days 13 and 18.
Part B: To assess the maximum observed plasma concentration (Cmax) of itraconazole following oral dosing of itraconazole alone and in the presence of radiprodil
Measured: Blood samples for plasma PK will be collected on Days 13 and 18.
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
Measured: Blood samples for plasma PK will be collected on Days 18 and 25.
Number of participants with abnormal laboratory test results
The clinical laboratory tests include hematology, serum chemisty and coagulation
Measured: From Screening to Day 30 and follow up visit 30 days post last dose
To assess the Columbia-Suicide Severity Rating Scale (C-SSRS) scores
The C-SSRS is a validated tool designed to systematically evaluate the severity and intensity of suicidal ideation and behavior.
Measured: From Screening to Day 30 and follow up visit 30 days post last dose
12-Lead ECG: Mean change from Baseline to End-of-Treatment in QT interval
Measured: From Screening to Day 30 and follow up visit 30 days post last dose
12-Lead ECG: Mean change from Baseline to End-of-Treatment in PR interval
Measured: From Screening to Day 30 and follow up visit 30 days post last dose
12-Lead ECG: Mean change from Baseline to End-of-Treatment in QRS interval
Measured: From Screening to Day 30 and follow up visit 30 days post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start8 May 2025
- Primary completion8 Jul 2025
- Study completion8 Jul 2025
Why it stopped: Study was terminated due to the lack of operational capabilities of the sites to segregate participants as needed.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- GRIN Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avance Clinical Pty Ltd.
- Responsible party
- Sponsor
- Investigators
- Russell Chin, Study director, GRIN Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965881
- Sponsor's protocol ID
- RAD-GRIN-504
- Status last verified
- Nov 2025
- First submitted
- 11 Apr 2025
- Last updated
- 21 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 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06965881
- Acronym / sponsor ID
- RAD-GRIN-504
- Keywords
- healthy adults, tuberous sclerosis, focal cortical dysplasia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to the lack of operational capabilities of the sites to segregate participants as needed.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GRIN Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Avance Clinical Pty Ltd.
- Study start
- 8 May 2025 (actual)
- Primary completion
- 8 Jul 2025 (actual)
- Study completion
- 8 Jul 2025 (actual)
- First posted
- 11 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, 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.
Detailed description
This is an open label study conducted in healthy adult volunteers. The study will be conducted in 2 parallel parts. A total of 36 participants will be enrolled in the study (N=18 per Part).
Part A: will enrol 18 participants to receive multiple oral doses of the radiprodil in the range of 7.5mg to 30mg with oral carbamazepine.
Part B: will enrol 18 participants to receive multiple oral doses of radiprodil in the range of 7.5mg to 15mg with oral itraconazole.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: Radiprodil with Carbamazepine | Experimental | Drug: Radiprodil with CarbamazepineParticipants will receive multiple oral doses of Radiprodil with Carbamazepine to evaluate the effect that carbamazepine may have on Radiprodil. |
| Part B: Radiprodil with Itraconazole | Experimental | Drug: Radiprodil with ItraconazoleParticipants will receive multiple oral doses of Radiprodil with Itraconazole to evaluate the effect that itraconazole may have on Radiprodil. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
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 with CarbamazepineParticipants 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. | Drug | Part A: Radiprodil with Carbamazepine |
| Radiprodil with ItraconazoleParticipants 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. | Drug | Part B: Radiprodil with Itraconazole |
Primary outcome
Part A: To assess the effect of oral carbamazepine on the maximum observed plasma concentration (Cmax) of oral dosing of radiprodil
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Blood samples will be collected Days 5 to 9 and 18 to 22
14 secondary outcomes
Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (SAEs), TEAEs Leading to Discontinuation and Severity of TEAEs
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Blood samples for plasma PK will be collected on Days 18 and 25.
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
Time frame: Blood samples for plasma PK will be collected on Days 18 and 25.
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
Time frame: Blood samples for plasma PK will be collected on Days 13 and 18.
Part B: To assess the maximum observed plasma concentration (Cmax) of itraconazole following oral dosing of itraconazole alone and in the presence of radiprodil
Time frame: Blood samples for plasma PK will be collected on Days 13 and 18.
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
Time frame: Blood samples for plasma PK will be collected on Days 18 and 25.
Number of participants with abnormal laboratory test results
Time frame: From Screening to Day 30 and follow up visit 30 days post last dose
To assess the Columbia-Suicide Severity Rating Scale (C-SSRS) scores
Time frame: From Screening to Day 30 and follow up visit 30 days post last dose
12-Lead ECG: Mean change from Baseline to End-of-Treatment in QT interval
Time frame: From Screening to Day 30 and follow up visit 30 days post last dose
12-Lead ECG: Mean change from Baseline to End-of-Treatment in PR interval
Time frame: From Screening to Day 30 and follow up visit 30 days post last dose
12-Lead ECG: Mean change from Baseline to End-of-Treatment in QRS interval
Time frame: From Screening to Day 30 and follow up visit 30 days post last dose
Results and safety
The study was stopped early (reason given: Study was terminated due to the lack of operational capabilities of the sites to segregate participants as needed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 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.
Russell Chin study director
GRIN Therapeutics, Inc.
2 sites 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 with Carbamazepine and Radiprodil with Itraconazole in people with Tuberous Sclerosis Complex (TSC) and Focal Cortical Dysplasia, run by GRIN Therapeutics, Inc. at 2 sites 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 7 inclusion and 14 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: stopped early, as of the sponsor's last update on 21 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 2 sites 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 was stopped early (reason given: Study was terminated due to the lack of operational capabilities of the sites to segregate participants as needed.). Results are not available in the source record.
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?
Part A: To assess the effect of oral carbamazepine on the maximum observed plasma concentration (Cmax) of oral dosing of radiprodil (time frame: Blood samples will be collected on Days 7 to 10 and 25 to 28.). The study lists 6 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 21 Nov 2025.