NCT06726382

KF2024#1-trial: Esketamine Interaction Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Esketamine is a drug which is used for depression treatment, to relieve pain and, in larger doses, in anesthesia. Spravato nasal spray is the only esketamine product on the market used for the treatment of depression, but the high price limits the use of the drug. The aim of this study is to compare the concentration of esketamine after nasal (licensed product Spravato) and oral administration with and without a CYP3A4 inhibitor. Grapefruit juice and cobicistat are studied as CYP3A4 inhibitors in the study. In an open four-phase, randomized, alternating study with 12 healthy volunteers, the subjects will receive Spravato 28 mg nasal or esketamine 28 mg oral with either grapefruit juice, cobicistat or water in the study facilities. Blood samples will be collected and esketamine pharmacokinetics will be monitored up to 24 hours postdose. Primary endpoint is area under the plasma concentration-time curve of esketamine.

Conditions

• Drug Interactions
• Food-drug Interaction

Interventions

Type	Name	Description
DRUG	Esketamine Nasal Spray	1 x 28 mg dose
DRUG	Esketamine 28 mg	1 x 5,6 ml p.o.
DRUG	Cobicistat 150 MG	1 x 150 mg tablet
OTHER	Grapefruit juice	250 ml grapefruit juice at 8.00 and 9.00 a.m. on the study day.

Timeline

• Start date: 2024-12-09
• Primary completion: 2025-04-29
• Completion: 2025-04-29
• First posted: 2024-12-10
• Last updated: 2026-03-05

Locations

1 site across 1 country: Finland