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A Study to Evaluate the Effect of Carbamazepine or Itraconazole on Radiprodil in Healthy Adult Participants
Sponsor: GRIN Therapeutics, Inc.
Summary
This is a Phase 1, open-label, 2-part study in healthy adult participants to evaluate the pharmacokinetics and safety of radiprodil when coadministered with either the CYP3A4 inducer carbamazepine or the CYP3A4 inhibitor itraconazole. Up to 36 participants will be enrolled, with approximately 18 participants in Part A and 18 participants in Part B.
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
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2026-06-08
Completion Date
2026-10-31
Last Updated
2026-10-21
Healthy Volunteers
Yes
Conditions
Interventions
Radiprodil
Radiprodil administered orally as a single dose of 30 mg in Part A or 15 mg in Part B under fed conditions.
Carbamazepine
Carbamazepine administered orally twice daily at doses of 100 mg, 200 mg, and 300 mg in Part A to evaluate the effect of CYP3A4 induction on the pharmacokinetics of radiprodil.
Itraconazole (200 mg)
Itraconazole administered orally at 200 mg once daily in Part B to evaluate the effect of CYP3A4 inhibition on the pharmacokinetics of radiprodil.
Locations (1)
California Clinical Trials Medical Group (CCTMG)
Glendale, California, United States