Drug interaction study for radiprodil halted early
NCT ID NCT06965881
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early-stage study looked at how two common drugs (carbamazepine and itraconazole) change the levels of radiprodil in the blood of 30 healthy adults. The goal was to understand safety and dosing for future use in neurological conditions like tuberous sclerosis. However, the study was terminated before completion.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radiprodil
- What could go wrong
- This was a very early (Phase 1) study in only 30 healthy people, not patients. It was terminated, so results may never be available.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
30 people
The number who actually took part.
- Started
-
May 2025
- Finished
-
Jul 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Healthy male and female adults between 18 and 55 years of age, inclusive, at Screening * Body mass index (BMI) between 18 and 32 kg/m2 (inclusive) and weighs at least 50 kg at Screening * 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 Exclusion Criteria: * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Nucleus Network Pty Ltd
Melbourne, Victoria, 3004, Australia
-
Q-Pharm Pty Ltd
Brisbane, Queensland, 4006, Australia
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