HealthyPhase 1NCT05979727
Dose-finding PKPD Trial for RE02 in Healthy Subjects
A Phase 1 study testing RE02 and Manitol in people with Healthy, run by Reconnect Labs at 1 site in Switzerland.
Trial summary
The goal of this clinical trial is to compare corresponding inter- and intraindividual pharmacokinetic and pharmacodynamic profiles including assessments of safety \& tolerability of three different doses against a placebo control. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- RE02 and Manitol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Nov 2023to 10 Dec 2023
- 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and capable to give informed consent for the participation in the study after it has been thoroughly explained
- Willing to refrain from drinking alcohol one day before testing days and caffeinated drinks at the testing days and from consuming psychoactive substances or other medications for 2 weeks before testing days and for the duration of the study
- Already experienced with psychedelic substances (at least 5 prior experiences - microdoses do not count)
- Able and willing to comply with all study requirements
- Informed consent form was signed
- Good knowledge of the German language
- Participant informs study physicians / project scientists about simultaneous treatment or therapy with other physicians and about current intake of psychotropic substances or medication
- Women of childbearing potential are required to use effective, established contraception, such as oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS), barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
Who cannot join
- Previous significant adverse response to a hallucinogenic drug
- Participation in another study where pharmaceutical compounds will be given
- Presence of Axis I affective, anxiety, or dissociative disorders
- Present or antecedent diagnosis of bipolar disorder (I, II, not otherwise specified), schizophrenia, schizoaffective disorder, psychosis, or other disorders from the psychotic spectrum
- First-degree relatives with present or antecedent schizophrenia, schizoaffective disorder, or bipolar disorder type I
- History of head trauma, seizures, cancer, or cerebrovascular accidents
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- Recent cardiac or brain surgery
- Current abuse of medication or psychotropic substances (including nicotine addiction) according to SCID I criteria
- Presence of major internal or neurological disorders (including sepsis, pheochromocytoma, thyrotoxicosis, drug-induced fibrosis, familiar or basilar artery migraine)
- Cardiovascular disease (hypertonia, coronary artery disease, heart insufficiency, myocardical infarction, coronary spastic angina)
- Peripheral vascular disease (thromboangiitis obliterans, luetic arteritis, severe arteriosclerosis, thrombophlebitis, Raynaud's disease)
- Cerebrovascular disease (e.g., stroke, intracranial bleeding / hemorrhage, intracranial aneurysm)
- Serious abnormalities in ECG or blood count/chemistry
- Liver or renal or pulmonary disease
- Current use of medications with significant interaction potential with MAOI (e.g., antidepressants, antipsychotics, psychostimulants, dopaminergic/serotonergic agents, anticonvulsants)
- high risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, serious current stressors, lack of social support)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Psychiatry Zurich
Zurich, Canton of Zurich, 8032
About this study
Official title: Double-blind, Randomized, Dose-response Study of RE02 in Healthy Subjects
The goal of this clinical trial is to compare corresponding inter- and intraindividual pharmacokinetic and pharmacodynamic profiles including assessments of safety \& tolerability of three different doses against a placebo control.
Read the detailed description
Participants will undergo a series of four study days with varying doses of RE02 and a placebo. The intervention is embedded in controlled environment and continuous psychological support. Pharmacokinetic and pharmacodynamic assessments are obtained over the course of 6 hours on each study visit to estimate dose-exposure relationship and drug-drug-interaction. Additionally, the occurrence of adverse events will be closely monitored throughout the whole study.
- Conditions
- Healthy
- Being tested
- RE02, Manitol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RE02Drug
Low, medium or high dose of RE02
ManitolDrug
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Manitol |
| Low dose of RE02 | Active comparator | Not described Receives: Drug: RE02 |
| Moderate dose of RE02 | Active comparator | Not described Receives: Drug: RE02 |
| High dose of RE02 | Active comparator | Not described Receives: Drug: RE02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter "Cmax"
Dose-dependent changes in Cmax of several doses of RE02
Measured: Changes from baseline to study days 1,2,3,4
Pharmacokinetic parameter "Area under the curve (AUC)"
Dose-dependent changes in AUC of several doses of RE02.
Measured: Changes from baseline to study days 1,2,3,4
Pharmacokinetic parameter "T1/2"
Dose-dependent changes in T1/2 of several doses of RE02.
Measured: Changes from baseline to study days 1,2,3,4
Incidence of Treatment-Emergent Adverse Events
Dose-dependent changes in incidence of adverse drug reactions
Measured: On study days 1,2,3,4
Blood count (Lab biochemistry)
Changes from baseline in blood count
Measured: Changes from baseline to End of Study, an average of 4 weeks
Clinical chemistry (Lab biochemistry)
Changes from baseline in any clinical chemistry parameter with potential clinical relevance.
Measured: Changes from baseline to End of Study, an average of 4 weeks
Blood coagulation (Lab biochemistry)
Changes from baseline in blood coagulation
Measured: Changes from baseline to End of Study, an average of 4 weeks
QT interval (12-lead Electrocardiogram [ECG])
Dose-dependent changes of QT intervals assessed by clinical 12-lead ECG)
Measured: Changes from baseline to study days 1,2,3,4
Blood pressure
Dose-dependent changes in systolic and diastolic blood pressure
Measured: Changes from baseline to study days 1,2,3,4
Heart rate
Dose-dependent changes in heart rate
Measured: Changes from baseline to study days 1,2,3,4
Temperature
Dose-dependent changes in temperature
Measured: Changes from baseline to study days 1,2,3,4
Subjective effects
Dose-dependent changes in trajectories of subjective effects
Measured: Changes from baseline to study days 1,2,3,4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start20 Nov 2023
- Primary completion10 Dec 2023
- Study completion10 Dec 2023
Why it stopped: The trial was closed due to futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reconnect Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erich Seifritz, Prof, Principal investigator, Psychiatric University Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979727
- Sponsor's protocol ID
- MEO-DMT-VR
- Status last verified
- Nov 2024
- First submitted
- 31 Jul 2023
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan available to date.
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Dose-response Study of RE02 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05979727
- Acronym / sponsor ID
- MEO-DMT-VR
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was closed due to futility
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Reconnect LabsIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 10 Dec 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 7 Aug 2023 (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.
The goal of this clinical trial is to compare corresponding inter- and intraindividual pharmacokinetic and pharmacodynamic profiles including assessments of safety \& tolerability of three different doses against a placebo control.
Detailed description
Participants will undergo a series of four study days with varying doses of RE02 and a placebo. The intervention is embedded in controlled environment and continuous psychological support. Pharmacokinetic and pharmacodynamic assessments are obtained over the course of 6 hours on each study visit to estimate dose-exposure relationship and drug-drug-interaction. Additionally, the occurrence of adverse events will be closely monitored throughout the whole study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Manitol |
| Low dose of RE02 | Active comparator | Drug: RE02 |
| Moderate dose of RE02 | Active comparator | Drug: RE02 |
| High dose of RE02 | Active comparator | Drug: RE02 |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Willing and capable to give informed consent for the participation in the study after it has been thoroughly explained
- Willing to refrain from drinking alcohol one day before testing days and caffeinated drinks at the testing days and from consuming psychoactive substances or other medications for 2 weeks before testing days and for the duration of the study
- Already experienced with psychedelic substances (at least 5 prior experiences - microdoses do not count)
- Able and willing to comply with all study requirements
- Informed consent form was signed
Key exclusion criteria (16 listed)
- Previous significant adverse response to a hallucinogenic drug
- Participation in another study where pharmaceutical compounds will be given
- Presence of Axis I affective, anxiety, or dissociative disorders
- Present or antecedent diagnosis of bipolar disorder (I, II, not otherwise specified), schizophrenia, schizoaffective disorder, psychosis, or other disorders from the psychotic spectrum
- First-degree relatives with present or antecedent schizophrenia, schizoaffective disorder, or bipolar disorder type I
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 |
|---|---|---|
| RE02Low, medium or high dose of RE02 | Drug | High dose of RE02, Low dose of RE02, Moderate dose of RE02 |
| ManitolPlacebo Comparator | Drug | Placebo |
Primary outcome
Pharmacokinetic parameter "Cmax"
Time frame: Changes from baseline to study days 1,2,3,4
Dose-dependent changes in Cmax of several doses of RE02
Pharmacokinetic parameter "Area under the curve (AUC)"
Time frame: Changes from baseline to study days 1,2,3,4
Dose-dependent changes in AUC of several doses of RE02.
Pharmacokinetic parameter "T1/2"
Time frame: Changes from baseline to study days 1,2,3,4
Dose-dependent changes in T1/2 of several doses of RE02.
Incidence of Treatment-Emergent Adverse Events
Time frame: On study days 1,2,3,4
Dose-dependent changes in incidence of adverse drug reactions
Blood count (Lab biochemistry)
Time frame: Changes from baseline to End of Study, an average of 4 weeks
Changes from baseline in blood count
Clinical chemistry (Lab biochemistry)
Time frame: Changes from baseline to End of Study, an average of 4 weeks
Changes from baseline in any clinical chemistry parameter with potential clinical relevance.
Blood coagulation (Lab biochemistry)
Time frame: Changes from baseline to End of Study, an average of 4 weeks
Changes from baseline in blood coagulation
QT interval (12-lead Electrocardiogram [ECG])
Time frame: Changes from baseline to study days 1,2,3,4
Dose-dependent changes of QT intervals assessed by clinical 12-lead ECG)
Blood pressure
Time frame: Changes from baseline to study days 1,2,3,4
Dose-dependent changes in systolic and diastolic blood pressure
Heart rate
Time frame: Changes from baseline to study days 1,2,3,4
Dose-dependent changes in heart rate
Temperature
Time frame: Changes from baseline to study days 1,2,3,4
Dose-dependent changes in temperature
Subjective effects
Time frame: Changes from baseline to study days 1,2,3,4
Dose-dependent changes in trajectories of subjective effects
Results and safety
The study was stopped early (reason given: The trial was closed due to futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No. No plan available to date.
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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.
Erich Seifritz, Prof principal investigator
Psychiatric University Hospital, Zurich
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 RE02 and Manitol in people with Healthy, run by Reconnect Labs at 1 site in Switzerland.
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 16 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: stopped early, as of the sponsor's last update on 27 Nov 2024. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: The trial was closed due to futility). Results are not available in the source record.
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?
Pharmacokinetic parameter "Cmax" (time frame: Changes from baseline to study days 1,2,3,4). The study lists 12 primary outcomes in all. 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 27 Nov 2024.