Study to Evaluate the Pharmacokinetics and Safety Effects Following Coadministration of Carbamazepine or Itraconazole With Radiprodil in Healthy Adults

Launched by GRIN THERAPEUTICS, INC. · May 2, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how two medications, carbamazepine and itraconazole, affect the way the body processes a new drug called radiprodil. Radiprodil may help people with conditions like Tuberous Sclerosis Complex (TSC) and other neurological disorders. The study will also check if taking radiprodil together with either of these medications is safe for healthy adults.

To participate in the trial, you need to be a healthy adult between 18 and 55 years old, with a body weight of at least 50 kg. Women must either not be able to get pregnant or agree to use effective birth control. Participants will need to attend several appointments for blood tests and follow study guidelines closely. This trial is currently not recruiting participants, but if you think you might be eligible, it’s a good idea to keep this information in mind for the future.

Gender

ALL

Eligibility 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.