Evaluating the effects of carbamazepine or itraconazole with radiprodil in healthy adults
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 study is testing how safe radiprodil is when taken with carbamazepine or itraconazole in healthy adults to see how these medications work together.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | GRIN Therapeutics, Inc. Industry-sponsored |
| Locations | 2 sites (Brisbane, Queensland and 1 other locations) |
| Trial ID | NCT06965881 on ClinicalTrials.gov |
What this trial studies
This Phase 1 open-label study aims to assess the pharmacokinetics and safety of radiprodil when coadministered with carbamazepine or itraconazole in healthy adult volunteers. The study consists of two parts, with 36 participants total, where Part A involves multiple doses of radiprodil with carbamazepine and Part B involves radiprodil with itraconazole. The primary focus is to understand how these medications interact and their safety profile in a controlled environment.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 to 55 with a BMI between 18 and 32 kg/m2.
Not a fit: Patients with known hypersensitivity to the study drugs or those with significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safe coadministration of radiprodil with other medications, potentially improving treatment options for neurological disorders.
How similar studies have performed: While this approach is not widely tested, similar pharmacokinetic studies have shown promise in understanding drug interactions.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Brisbane, Queensland and 1 other locations
- Q-Pharm Pty Ltd — Brisbane, Queensland, Australia (Recruiting)
- Nucleus Network Pty Ltd — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Russell Chin
- Email: ClinicalTrials@GrinTherapeutics.com
- Phone: +1-877-225-0014
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.