Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE1
12 participants
INTERVENTIONAL
2024-12-09
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Esketamine Nasal Spray
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.
Esketamine Nasal Spray
1 x 28 mg dose
Esketamine p.o. and water
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.
Esketamine 28 mg
1 x 5,6 ml p.o.
Esketamine p.o. and grapefruit juice
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.
Esketamine 28 mg
1 x 5,6 ml p.o.
Esketamine p.o. and Cobisistat
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.
Esketamine 28 mg
1 x 5,6 ml p.o.
Cobicistat 150 MG
1 x 150 mg tablet
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Esketamine Nasal Spray
1 x 28 mg dose
Esketamine 28 mg
1 x 5,6 ml p.o.
Cobicistat 150 MG
1 x 150 mg tablet
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
45 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Helsinki
OTHER
Helsinki University Central Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Janne Backman
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Janne T Backman, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Helsinki University Central Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Clinical Pharmacology
Helsinki, , Finland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Janne T Backman, MD, PhD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-516892-34-00
Identifier Type: CTIS
Identifier Source: secondary_id
KF2024#1
Identifier Type: -
Identifier Source: org_study_id