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Completed

NCT Number: NCT06726382

KF2024#1-trial: Esketamine Interaction Study

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.

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Key information

Conditions

Drug Interactions Food-drug Interaction

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Clinical Pharmacology

Helsinki, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • signed consent
  • age 18-45 years
  • healthy
  • no indications of substance abuse
  • Accepted results from laboratory tests (blood hemoglobin, basic blood count and blood platelets, alanine aminotransferase, alkaline phosphatase, glutamyl transferase, creatinine, plasma potassium and sodium). Negative pregnancy test result (serum human chorionic gonadotropin) for women.
  • no significant abnormalities in the ECG
  • systolic blood pressure 140 mmHg-100 mmHg
  • heart rate ≥50/minute

Exclusion criteria

  • significant illness
  • less than 3 months since the last clinical trial
  • less than 3 months after donating blood
  • significant overweight/poor veins
  • BMI below 18.5 kg/m2
  • past or present mood disorder or suicidality
  • substance abuse
  • systolic blood pressure below 100 mmHg or above 140 mmHg
  • heart rate <50/minute
  • conduction disorder or other significant abnormality in the ECG
  • smoking
  • regular medication (including e-pills and other preparations containing estrogens)
  • pregnancy or its planning or breastfeeding
  • hypersensitivity to investigational drugs or excipients of medicinal products
  • use of natural products (such as St. John's wort)

Treatment and study plan

Esketamine Nasal Spray

Drug

1 x 28 mg dose

Other names: Esketamine, Spravato, Janssen-Cilag International NV

Esketamine 28 mg

Drug

1 x 5,6 ml p.o.

Other names: Esketamine Kalceks 5 mg/ml, AS KALCEKS

Cobicistat 150 MG

Drug

1 x 150 mg tablet

Other names: Tybost 150 mg tablet, GILEAD

Grapefruit Juice

Other

250 ml grapefruit juice at 8.00 and 9.00 a.m. on the study day.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Blood pressure

    Time frame: 0, 60, 120 and 240 minutes after administration

    Blood pressure (safety parameter)

  7. Heart rate

    Time frame: 0, 60, 120 and 240 minutes after administration

    Heart rate (Safety parameter)

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • University of Helsinki

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2024
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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