Drug Drug InteractionPhase 1KF2025#1NCT07462559
KF2025#1 Trial: Ketamine, Cannabidiol and Cobicistat Interaction Study
A Phase 1 study testing Ketamine 10 mg/ml oral solution, UK special, Cobisistat Tybost 150 mg and Cannabidiol Epidyolex 100 mg/ml in people with Drug Drug Interaction, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
Ketamine is a dissociative anesthetic developed approximately 60 years ago. Both ketamine and its isomer, esketamine, have been used for over 20 years in the treatment of treatment-resistant depression. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Drug Interaction
- What is being tested?
- Ketamine 10 mg/ml oral solution, UK special, Cobisistat Tybost 150 mg and Cannabidiol Epidyolex 100 mg/ml
- 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
- 4 Mar 2026to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- written informed consent
- age 18-45 years
- healthy
- no indications of substance abuse
- acceptable values in laboratory tests: hemoglobin must be at least at the lower limit of the reference range (men 134 g/l, women 117 g/l), liver values at most at the upper limit of the reference range (P -ALAT: women below 35 U/l, men below 50 U/l; P -AFOS: 35 U/l - 105 U/l; P -GT: women less than 40 U/l, men less than 60 U/l; P -Bil: less than 20 umol/l) and in other results (B -PVKT, P -Krea, P -K and P -Na) only minor values that deviate from normal values, which according to the examining physician's assessment are clinically insignificant. Drug screening (U -Huum-PS) and in women the pregnancy test (P-hCG-tot) should be negative.
- No significant abnormalities in the ECG
Who cannot join
- significant illness
- mood disorder or suicidality
- substance abuse
- systolic blood pressure over 150 mmHg
- conduction disorder or other significant abnormality in the ECG
- smoking
Show all 14Show fewer
- regular medication, excluding contraceptives that do not contain estrogens
- pregnancy or its planning or breastfeeding
- less than 3 months from the previous clinical trial
- less than 3 months since donating blood
- significant overweight or underweight
- difficult to find elbow veins
- 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. Contact the study team or a site near you to ask about taking part.
Laura Tervala contact
Finland1 site
Department of Clinical Pharmacology
Helsinki
Janne T Backman, MD, PhD, +35894711, janne.backman@hus.fi
About this study
Ketamine is a dissociative anesthetic developed approximately 60 years ago. Both ketamine and its isomer, esketamine, have been used for over 20 years in the treatment of treatment-resistant depression. Other treatment options for this type of depression include combinations of antidepressants, other medications used in depression treatment (such as lithium), psychotherapy, electroconvulsive therapy, and repetitive transcranial magnetic stimulation. The advantage of ketamine and its stereoisomer, esketamine, over other treatment options is their rapidly emerging antidepressant effect, which becomes apparent within the first few days of treatment.
Ketamine is primarily metabolized by the cytochrome P450 (CYP) 3A4 enzyme, but also by the CYP2B6 and CYP2C9 enzymes. However, information on the significance of these different enzymes in ketamine metabolism is incomplete. Due to extensive first-pass metabolism, the bioavailability of orally administered ketamine varies significantly and is, on average, only 8-24%. This makes ketamine unsuitable for oral administration. In the treatment of depression, ketamine is administered as a slow intravenous infusion.
Read more
The concurrent use of medications that inhibit ketamine metabolism can significantly increase the bioavailability of orally administered ketamine. Cobicistat is a potent inhibitor of the CYP3A4 enzyme, which can significantly increase ketamine bioavailability and reduce interindividual variability by inhibiting ketamine's CYP3A4-mediated metabolism. This might enable the oral use of ketamine.
Cannabidiol is a cannabinoid that does not have addictive effects, but may have antidepressant and anxiolytic effects. Cannabidiol might reduce the dissociative side effects associated with ketamine treatment. Clinically, cannabidiol appears to moderately inhibit CYP enzymes in the order of potency: CYP2C19 > CYP2C9 > CYP3A > CYP1A2, and based on in vitro data, it also somewhat inhibits the CYP2B6 enzyme, which is involved in ketamine metabolism. However, its effect on ketamine concentrations cannot be assessed based on current knowledge.
The purpose of this study is to investigate the potential effects of cannabidiol, cobicistat, and their concurrent administration on the pharmacokinetics of orally administered ketamine. A secondary objective is to study the effect of cannabidiol on ketamine-induced side effects.
Study Methodology: This is a four-phase, randomized, open-label, crossover study involving 12 healthy volunteers. On study days, participants will receive a 56 mg oral dose of ketamine in the research facility, alternately with water, cannabidiol, cobicistat, or both cannabidiol and cobicistat. There will be at least a two-week washout period between study days.
The pharmacokinetics of ketamine and other study drugs will be investigated by taking blood samples according to a separate schedule for 11 hours after administration on the study day and the following morning. Pharmacokinetic parameters will be calculated from plasma concentrations of ketamine, cobicistat, cannabidiol, and their metabolites. The primary outcome measure is the total area under the curve (AUC0-∞) of ketamine. Additionally, the effects of the drugs on blood pressure, heart rate, and subjective adverse feeling of the study participants will be examined.
- Conditions
- Drug Drug Interaction
- Being tested
- Ketamine 10 mg/ml oral solution, UK special, Cobisistat Tybost 150 mg, Cannabidiol Epidyolex 100 mg/ml
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine 10 mg/ml oral solution, UK specialDrug
1 x 56 mg (5,6 ml) p.o.
Cobisistat Tybost 150 mgDrug
1 x 150 mg p.o.
Cannabidiol Epidyolex 100 mg/mlDrug
1 x 700 mg (7 ml) p.o.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Active comparator | 250 ml water at 8.00 and 9.00 a.m. on the study day. Study drug dose (Ketamine 10 mg/ml oral solution, UK special, 56 mg) p.o. at 9.00 a.m. on the study day. Receives: Drug: Ketamine 10 mg/ml oral solution, UK special |
| Ketamine and cobisistat | Active comparator | 250 ml water at 8.00 and 9.00 a.m. on the study day. Study drug dose (Cobisistat Tybost 150 mg) p.o. at 8.00 a.m. on the study day. Study drug dose (Ketamine 10 mg/ml oral solution, UK special, 56 mg) p.o. at 9.00 a.m. on the study day. Receives: Drug: Ketamine 10 mg/ml oral solution, UK special; Drug: Cobisistat Tybost 150 mg |
| Ketamine and cannabidiol | Active comparator | 250 ml water at 8.00 and 9.00 a.m. on the study day. Study drug dose (Cannabidiol Epidyolex 100 mg/ml, 700 mg) p.o. at 8.00 a.m. on the study day. Study drug dose (Ketamine 10 mg/ml oral solution, UK special, 56 mg) p.o. at 9.00 a.m. on the study day. Receives: Drug: Ketamine 10 mg/ml oral solution, UK special; Drug: Cannabidiol Epidyolex 100 mg/ml |
| Ketamine, cannabidiol and cobisistat | Active comparator | 250 ml water at 8.00 and 9.00 a.m. on the study day. Study drug dose (Cannabidiol Epidyolex 100 mg/ml, 700 mg) and (Cobisistat Tybost 150 mg) p.o. at 8.00 a.m. on the study day. Study drug dose (Ketamine 10 mg/ml oral solution, UK special, 56 mg) p.o. at 9.00 a.m. on the study day. Receives: Drug: Ketamine 10 mg/ml oral solution, UK special; Drug: Cobisistat Tybost 150 mg; Drug: Cannabidiol Epidyolex 100 mg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration - time curve (AUC) of ketamine
Measured: Prior to and 15, 30, 45, 60, 75, 90 minutes and 2, 3, 4, 5, 7, 9, 11 and 23 hours after administration the drug.
Secondary outcomes (8)
Area under the plasma concentration - time curve (AUC) for kobisistat, cannabidiol and their metabolites
Measured: Prior to and 15, 30, 45, 60, 75, 90 minutes and 2, 3, 4, 5, 7, 9, 11 and 23 hours after administration the drug.
Area under the plasma concentration - time curve (AUC) for ketamine metabolites
Measured: Prior to and 15, 30, 45, 60, 75, 90 minutes and 2, 3, 4, 5, 7, 9, 11 and 23 hours after administration the drug.
Peak plasma concentration for ketamine, kobisistat, cannabidiol and their metabolites
Measured: Prior to and 15, 30, 45, 60, 75, 90 minutes and 2, 3, 4, 5, 7, 9, 11 and 23 hours after administration the drug.
Half-life for ketamine, kobisistat, cannabidiola and their metabolites
Measured: Prior to and 15, 30, 45, 60, 75, 90 minutes and 2, 3, 4, 5, 7, 9, 11 and 23 hours after administration the drug.
Time to peak plasma concentration for ketamine, kobisistat, cannabidiola and their metabolites
Measured: Prior to and 15, 30, 45, 60, 75, 90 minutes and 2, 3, 4, 5, 7, 9, 11 and 23 hours after administration the drug.
Blood pressure
Measured: 0, 60, 12 and 240 minutes after administration
Heart rate
Measured: 0, 60, 12 and 240 minutes after administration
Subjective adverse effects of ketamine and cannabidiol
Measured: 0, 30, 60, 120, 240 and 360 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 Mar 2026
- Study start4 Mar 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Drug InteractionStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- 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 (estimated)
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
- NCT07462559
- Sponsor's protocol ID
- KF2025#1
- Other IDs
- 2025-523817-27-00, 2025
- Acronym
- KF2025#1
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 10 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 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KF2025#1 Trial: Ketamine, Cannabidiol and Cobicistat Interaction Study
- ClinicalTrials.gov ID
- NCT07462559
- Acronym / sponsor ID
- KF2025#1 / KF2025#1
- Conditions
- Drug Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Helsinki
- Study start
- 4 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Mar 2026 (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.
Ketamine is a dissociative anesthetic developed approximately 60 years ago. Both ketamine and its isomer, esketamine, have been used for over 20 years in the treatment of treatment-resistant depression. Other treatment options for this type of depression include combinations of antidepressants, other medications used in depression treatment (such as lithium), psychotherapy, electroconvulsive therapy, and repetitive transcranial magnetic stimulation. The advantage of ketamine and its stereoisomer, esketamine, over other treatment options is their rapidly emerging antidepressant effect, which becomes apparent within the first few days of treatment.
Ketamine is primarily metabolized by the cytochrome P450 (CYP) 3A4 enzyme, but also by the CYP2B6 and CYP2C9 enzymes. However, information on the significance of these different enzymes in ketamine metabolism is incomplete. Due to extensive first-pass metabolism, the bioavailability of orally administered ketamine varies significantly and is, on average, only 8-24%. This makes ketamine unsuitable for oral administration. In the treatment of depression, ketamine is administered as a slow intravenous infusion.
The concurrent use of medications that inhibit ketamine metabolism can significantly increase the bioavailability of orally administered ketamine. Cobicistat is a potent inhibitor of the CYP3A4 enzyme, which can significantly increase ketamine bioavailability and reduce interindividual variability by inhibiting ketamine's CYP3A4-mediated metabolism. This might enable the oral use of ketamine.
Cannabidiol is a cannabinoid that does not have addictive effects, but may have antidepressant and anxiolytic effects. Cannabidiol might reduce the dissociative side effects associated with ketamine treatment. Clinically, cannabidiol appears to moderately inhibit CYP enzymes in the order of potency: CYP2C19 > CYP2C9 > CYP3A > CYP1A2, and based on in vitro data, it also somewhat inhibits the CYP2B6 enzyme, which is involved in ketamine metabolism. However, its effect on ketamine concentrations cannot be assessed based on current knowledge.
The purpose of this study is to investigate the potential effects of cannabidiol, cobicistat, and their concurrent administration on the pharmacokinetics of orally administered ketamine. A secondary objective is to study the effect of cannabidiol on ketamine-induced side effects.
Study Methodology: This is a four-phase, randomized, open-label, crossover study involving 12 healthy volunteers. On study days, participants will receive a 56 mg oral dose of ketamine in the research facility, alternately with water, cannabidiol, cobicistat, or both cannabidiol and cobicistat. There will be at least a two-week washout period between study days.
The pharmacokinetics of ketamine and other study drugs will be investigated by taking blood samples according to a separate schedule for 11 hours after administration on the study day and the following morning. Pharmacokinetic parameters will be calculated from plasma concentrations of ketamine, cobicistat, cannabidiol, and their metabolites. The primary outcome measure is the total area under the curve (AUC0-∞) of ketamine. Additionally, the effects of the drugs on blood pressure, heart rate, and subjective adverse feeling of the study participants will be examined.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Active comparator | Drug: Ketamine 10 mg/ml oral solution, UK special250 ml water at 8.00 and 9.00 a.m. on the study day. Study drug dose (Ketamine 10 mg/ml oral solution, UK special, 56 mg) p.o. at 9.00 a.m. on the study day. |
| Ketamine and cobisistat | Active comparator | Drug: Ketamine 10 mg/ml oral solution, UK special, Drug: Cobisistat Tybost 150 mg250 ml water at 8.00 and 9.00 a.m. on the study day. Study drug dose (Cobisistat Tybost 150 mg) p.o. at 8.00 a.m. on the study day. Study drug dose (Ketamine 10 mg/ml oral solution, UK special, 56 mg) p.o. at 9.00 a.m. on the study day. |
| Ketamine and cannabidiol | Active comparator | Drug: Ketamine 10 mg/ml oral solution, UK special, Drug: Cannabidiol Epidyolex 100 mg/ml250 ml water at 8.00 and 9.00 a.m. on the study day. Study drug dose (Cannabidiol Epidyolex 100 mg/ml, 700 mg) p.o. at 8.00 a.m. on the study day. Study drug dose (Ketamine 10 mg/ml oral solution, UK special, 56 mg) p.o. at 9.00 a.m. on the study day. |
| Ketamine, cannabidiol and cobisistat | Active comparator | Drug: Ketamine 10 mg/ml oral solution, UK special, Drug: Cobisistat Tybost 150 mg, Drug: Cannabidiol Epidyolex 100 mg/ml250 ml water at 8.00 and 9.00 a.m. on the study day. Study drug dose (Cannabidiol Epidyolex 100 mg/ml, 700 mg) and (Cobisistat Tybost 150 mg) p.o. at 8.00 a.m. on the study day. Study drug dose (Ketamine 10 mg/ml oral solution, UK special, 56 mg) p.o. 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 (6 listed)
- written informed consent
- age 18-45 years
- healthy
- no indications of substance abuse
- acceptable values in laboratory tests: hemoglobin must be at least at the lower limit of the reference range (men 134 g/l, women 117 g/l), liver values at most at the upper limit of the reference range (P -ALAT: women below 35 U/l, men below 50 U/l; P -AFOS: 35 U/l - 105 U/l; P -GT: women less than 40 U/l, men less than 60 U/l; P -Bil: less than 20 umol/l) and in other results (B -PVKT, P -Krea, P -K and P -Na) only minor values that deviate from normal values, which according to the examining physician's assessment are clinically insignificant. Drug screening (U -Huum-PS) and in women the pregnancy test (P-hCG-tot) should be negative.
Key exclusion criteria (14 listed)
- significant illness
- mood disorder or suicidality
- substance abuse
- systolic blood pressure over 150 mmHg
- conduction disorder or other significant abnormality in the ECG
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 |
|---|---|---|
| Ketamine 10 mg/ml oral solution, UK special1 x 56 mg (5,6 ml) p.o. | Drug | Ketamine, Ketamine and cannabidiol, Ketamine and cobisistat, Ketamine, cannabidiol and cobisistat |
| Cobisistat Tybost 150 mg1 x 150 mg p.o. | Drug | Ketamine and cobisistat, Ketamine, cannabidiol and cobisistat |
| Cannabidiol Epidyolex 100 mg/ml1 x 700 mg (7 ml) p.o. | Drug | Ketamine and cannabidiol, Ketamine, cannabidiol and cobisistat |
Primary outcome
Area under the plasma concentration - time curve (AUC) of ketamine
Time frame: Prior to and 15, 30, 45, 60, 75, 90 minutes and 2, 3, 4, 5, 7, 9, 11 and 23 hours after administration the drug.
8 secondary outcomes
Area under the plasma concentration - time curve (AUC) for kobisistat, cannabidiol and their metabolites
Time frame: Prior to and 15, 30, 45, 60, 75, 90 minutes and 2, 3, 4, 5, 7, 9, 11 and 23 hours after administration the drug.
Area under the plasma concentration - time curve (AUC) for ketamine metabolites
Time frame: Prior to and 15, 30, 45, 60, 75, 90 minutes and 2, 3, 4, 5, 7, 9, 11 and 23 hours after administration the drug.
Peak plasma concentration for ketamine, kobisistat, cannabidiol and their metabolites
Time frame: Prior to and 15, 30, 45, 60, 75, 90 minutes and 2, 3, 4, 5, 7, 9, 11 and 23 hours after administration the drug.
Half-life for ketamine, kobisistat, cannabidiola and their metabolites
Time frame: Prior to and 15, 30, 45, 60, 75, 90 minutes and 2, 3, 4, 5, 7, 9, 11 and 23 hours after administration the drug.
Time to peak plasma concentration for ketamine, kobisistat, cannabidiola and their metabolites
Time frame: Prior to and 15, 30, 45, 60, 75, 90 minutes and 2, 3, 4, 5, 7, 9, 11 and 23 hours after administration the drug.
Blood pressure
Time frame: 0, 60, 12 and 240 minutes after administration
Heart rate
Time frame: 0, 60, 12 and 240 minutes after administration
Subjective adverse effects of ketamine and cannabidiol
Time frame: 0, 30, 60, 120, 240 and 360 minutes after administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 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.
Laura Tervala contact
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 Ketamine 10 mg/ml oral solution, UK special, Cobisistat Tybost 150 mg and Cannabidiol Epidyolex 100 mg/ml in people with Drug 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 6 inclusion and 14 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: opening soon, as of the sponsor's last update on 10 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janne T Backman, MD, PhD (+35894711, janne.backman@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration - time curve (AUC) of ketamine (time frame: Prior to and 15, 30, 45, 60, 75, 90 minutes and 2, 3, 4, 5, 7, 9, 11 and 23 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 10 Mar 2026.