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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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
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

Other trials in Australia

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 groups in NCT06965881
Study groupRoleWhat they receive
Part A: Radiprodil with CarbamazepineExperimentalParticipants 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 ItraconazoleExperimentalParticipants 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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)

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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. 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

  13. 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

  14. 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.

  1. First posted11 May 2025
  2. Study start8 May 2025
  3. Primary completion8 Jul 2025
  4. 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

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)
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

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?

On the ClinicalTrials.gov record for NCT06965881.

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.

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