Drug InteractionsPhase 1NCT06726382
KF2024#1-trial: Esketamine Interaction Study
A Phase 1 study testing Esketamine Nasal Spray, Esketamine 28 mg and Cobicistat 150 MG in people with Drug Interactions and Food-drug Interaction, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Interactions, Food-drug Interaction
- What is being tested?
- Esketamine Nasal Spray, Esketamine 28 mg and Cobicistat 150 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFinland
- Study dates
- 9 Dec 2024to 29 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Drug Interactions, Food-drug Interaction
- Being tested
- Esketamine Nasal Spray, Esketamine 28 mg, Cobicistat 150 MG, Grapefruit juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esketamine Nasal SprayDrug
Also called Esketamine, Spravato, Janssen-Cilag International NV
1 x 28 mg dose
Esketamine 28 mgDrug
Also called Esketamine Kalceks 5 mg/ml, AS KALCEKS
1 x 5,6 ml p.o.
Cobicistat 150 MGDrug
Also called Tybost 150 mg tablet, GILEAD
1 x 150 mg tablet
Grapefruit juiceOther
250 ml grapefruit juice at 8.00 and 9.00 a.m. on the study day.
| Study group | Role | What they receive |
|---|---|---|
| Esketamine Nasal Spray | Active comparator | 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. Receives: Drug: Esketamine Nasal Spray |
| Esketamine p.o. and water | Experimental | 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. Receives: Drug: Esketamine 28 mg |
| Esketamine p.o. and grapefruit juice | Experimental | 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. Receives: Drug: Esketamine 28 mg; Other: Grapefruit juice |
| Esketamine p.o. and Cobisistat | Experimental | 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. Receives: Drug: Esketamine 28 mg; Drug: Cobicistat 150 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration - time curve of esketamine
Measured: 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 (7)
Peak plasma concentration for both esketamine and its metabolites
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 0, 60, 120 and 240 minutes after administration
Heart rate
Heart rate (Safety parameter)
Measured: 0, 60, 120 and 240 minutes after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start9 Dec 2024
- Primary completion29 Apr 2025
- Study completion29 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug InteractionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki
- Responsible party
- Principal investigator, Janne Backman, Helsinki University Central Hospital
- Investigators
- Janne T Backman, MD, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726382
- Sponsor's protocol ID
- KF2024#1
- Other IDs
- 2024-516892-34-00
- Status last verified
- Mar 2026
- First submitted
- 3 Dec 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KF2024#1-trial: Esketamine Interaction Study
- ClinicalTrials.gov ID
- NCT06726382
- Acronym / sponsor ID
- KF2024#1
- Conditions
- Drug Interactions, Food-drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Helsinki
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 29 Apr 2025 (actual)
- Study completion
- 29 Apr 2025 (actual)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Esketamine Nasal Spray | Active comparator | Drug: Esketamine Nasal Spray250 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. |
| Esketamine p.o. and water | Experimental | Drug: Esketamine 28 mg250 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. |
| Esketamine p.o. and grapefruit juice | Experimental | Drug: Esketamine 28 mg, Other: Grapefruit juice250 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. |
| Esketamine p.o. and Cobisistat | Experimental | Drug: Esketamine 28 mg, Drug: Cobicistat 150 MG150 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esketamine Nasal SprayAlso: Esketamine, Spravato, Janssen-Cilag International NV1 x 28 mg dose | Drug | Esketamine Nasal Spray |
| Esketamine 28 mgAlso: Esketamine Kalceks 5 mg/ml, AS KALCEKS1 x 5,6 ml p.o. | Drug | Esketamine p.o. and Cobisistat, Esketamine p.o. and grapefruit juice, Esketamine p.o. and water |
| Cobicistat 150 MGAlso: Tybost 150 mg tablet, GILEAD1 x 150 mg tablet | Drug | Esketamine p.o. and Cobisistat |
| Grapefruit juice250 ml grapefruit juice at 8.00 and 9.00 a.m. on the study day. | Other | Esketamine p.o. and grapefruit juice |
Primary outcome
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.
7 secondary outcomes
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
Time frame: 0, 60, 120 and 240 minutes after administration
Heart rate
Time frame: 0, 60, 120 and 240 minutes after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janne T Backman, MD, PhD principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Esketamine Nasal Spray, Esketamine 28 mg and Cobicistat 150 MG in people with Drug Interactions and Food-drug Interaction, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026; AzTrials last refreshed its copy on 28 Oct 2026.