Study to Evaluate the Pharmacokinetics and Safety Effects Following Coadministration of Carbamaze… (NCT06965881) | Clinical Trial Compass
TerminatedPhase 1
Study to Evaluate the Pharmacokinetics and Safety Effects Following Coadministration of Carbamazepine or Itraconazole With Radiprodil in Healthy Adults
Stopped: Study was terminated due to the lack of operational capabilities of the sites to segregate participants as needed.
Australia30 participantsStarted 2025-05-08
Plain-language 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. In addition, the safety and tolerability of radiprodil given together with oral carbamazepine or itraconazole will be assessed.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 alcoho…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part A: To assess the effect of oral carbamazepine on the maximum observed plasma concentration (Cmax) of oral dosing of radiprodil
Timeframe: 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
Timeframe: 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)
Timeframe: 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)
Timeframe: 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
Timeframe: 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
Timeframe: Blood samples will be collected Days 5 to 9 and 18 to 22