Phase 1Active, not recruiting
A Study to Evaluate the Effect of Carbamazepine or Itraconazole on Radiprodil in Healthy Adult Participants
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
- Sponsor
- GRIN Therapeutics, Inc. (Industry)
- Enrollment
- 36 planned
- Conditions
- Healthy Adult Participants
- Interventions
- Radiprodil; Carbamazepine; Itraconazole (200 mg)
- Ages
- adults
- Registry
- NCT07884734
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- AUClast of Radiprodil - Part A
- AUCinf of Radiprodil - Part A
- Cmax of Radiprodil - Part A
- AUClast of Radiprodil - Part B
History
Primary completion
Registered
Started