A Phase 1 interventional study of Esketamine Nasal Spray and Esketamine 28 mg in Drug Interactions and Food-drug Interaction, sponsored by Helsinki University Central Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by Helsinki University Central Hospital · Phase 1, Interventional, and Basic science
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.
Helsinki University Central Hospital is the lead sponsor of 299 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
250 ml water at 8.00 and 9.00 a.m. on the study day. Study drug dose (Esketamine Spravato, 28 mg) nasally at 9.00 a.m. on the study day.
Drug: Esketamine Nasal Spray
250 ml water at 8.00 and 9.00 a.m. on the study day. Study drug dose (Esketamine Kalceks 5 mg/ml, 28 mg) p.o. at 9.00 a.m. on the study day.
Drug: Esketamine 28 mg
250 ml grapefruit juice at 8.00 and 9.00 a.m. on the study day. Study drug dose (Esketamine Kalceks 5 mg/ml, 28 mg) p.o. at 9.00 a.m. on the study day.
Drug: Esketamine 28 mg · Other: Grapefruit juice
150 mg Cobisistat and 250 ml water at 8.00 a.m. on the study day. Study drug dose (Esketamine Kalceks 5 mg/ml, 28 mg) p.o. and 250 ml water at 9.00 a.m. on the study day.
Drug: Esketamine 28 mg · Drug: Cobicistat 150 MG
1 x 28 mg dose
Also known as: Esketamine, Spravato, Janssen-Cilag International NV
1 x 5,6 ml p.o.
Also known as: Esketamine Kalceks 5 mg/ml, AS KALCEKS
1 x 150 mg tablet
Also known as: Tybost 150 mg tablet, GILEAD
250 ml grapefruit juice at 8.00 and 9.00 a.m. on the study day.
Area under the plasma concentration - time curve of esketamine
Time frame: Prior to and 10, 20, 30, 40, 50, 60, 75, 90, 105 minutes and 2 , 3, 4, 6, 8, 10, 12 and 24 hours after administration the drug.
Peak plasma concentration for both esketamine and its metabolites
Time frame: Prior to and 10, 20, 30, 40, 50, 60, 75, 90, 105 minutes and 2 , 3, 4, 6, 8, 10, 12 and 24 hours after administration the drug.
Half-life for both esketamine and its metabolites
Time frame: Prior to and 10, 20, 30, 40, 50, 60, 75, 90, 105 minutes and 2 , 3, 4, 6, 8, 10, 12 and 24 hours after administration the drug.
Time to peak plasma concentration for both esketamine and its metabolites
Time frame: Prior to and 10, 20, 30, 40, 50, 60, 75, 90, 105 minutes and 2 , 3, 4, 6, 8, 10, 12 and 24 hours after administration the drug.
Fractional areas under concentration-time curve (AUC) for both esketamine and its metabolites
Time frame: Prior to and 10, 20, 30, 40, 50, 60, 75, 90, 105 minutes and 2 , 3, 4, 6, 8, 10, 12 and 24 hours after administration the drug.
Areas under concentration-time curve (AUC) for esketamine metabolites
Time frame: Prior to and 10, 20, 30, 40, 50, 60, 75, 90, 105 minutes and 2 , 3, 4, 6, 8, 10, 12 and 24 hours after administration the drug.
Blood pressure
Blood pressure (safety parameter)
Time frame: 0, 60, 120 and 240 minutes after administration
Heart rate
Heart rate (Safety parameter)
Time frame: 0, 60, 120 and 240 minutes after administration
Plan to share: No
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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Helsinki University Central Hospital