KF2024#1-trial: Esketamine Interaction Study

Launched by HELSINKI UNIVERSITY CENTRAL HOSPITAL · Dec 9, 2024

Keywords

ClinConnect Summary

The KF2024#1-trial is a study focused on understanding how esketamine, a medication used to treat depression, interacts with certain foods and drugs. Specifically, the trial will compare how well the body absorbs esketamine when taken as a nasal spray (the approved product called Spravato) versus when it’s taken as a pill, and whether consuming grapefruit juice or using a medication called cobicistat affects this process. The study will involve 12 healthy volunteers who will participate in different phases, receiving either the nasal spray or the pill along with grapefruit juice, cobicistat, or water. Researchers will collect blood samples to track how esketamine levels change over 24 hours.

To be eligible for this trial, participants must be healthy adults aged 18 to 45, with no history of substance abuse or significant health problems. They will need to pass certain health tests and meet specific criteria, such as having a stable heart rate and blood pressure. Participants can expect to spend time at the study facility and will have their blood monitored during the trial. It's important to know that the study is not yet recruiting, and it will help researchers learn more about how esketamine works, which could improve treatment options for depression in the future.

Gender

ALL

Eligibility criteria

• 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)