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ACTIVE NOT RECRUITING
NCT07884734
PHASE1

A Study to Evaluate the Effect of Carbamazepine or Itraconazole on Radiprodil in Healthy Adult Participants

Sponsor: GRIN Therapeutics, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

Radiprodil

Radiprodil administered orally as a single dose of 30 mg in Part A or 15 mg in Part B under fed conditions.

DRUG

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.

DRUG

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