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KF2024#1-trial: Esketamine Interaction Study

Not yet recruitingRegisteredCTG

This open-label, Phase I trial (n=12) will investigate the effects of different methods of esketamine administration (28 mg nasal spray vs. 28 mg oral solution) with and without CYP3A4 inhibitors (grapefruit juice or cobicistat) on drug absorption and metabolism.

Details

Open, randomized four-period crossover in 12 healthy volunteers comparing intranasal Esketamine (Spravato 28 mg) and oral esketamine 28 mg with water, grapefruit juice, or cobicistat to assess effects on plasma concentrations.

Primary outcome is area under the plasma concentration–time curve (AUC) of esketamine; PK sampling to 24 hours postdose with safety and tolerability monitoring.

Topics:Healthy Volunteers

Registry

Registry linkNCT06726382