Dose-finding PKPD Trial for RE02 in Healthy Subjects

Sponsor

Reconnect Labs (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05979727

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: RE02 Drug: Manitol	Phase 1

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

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Other

Official Title:

Double-blind, Randomized, Dose-response Study of RE02 in Healthy Subjects

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: Manitol Placebo Comparator
Active Comparator: Low dose of RE02	Drug: RE02 Low, medium or high dose of RE02
Active Comparator: Moderate dose of RE02	Drug: RE02 Low, medium or high dose of RE02
Active Comparator: High dose of RE02	Drug: RE02 Low, medium or high dose of RE02

Outcome Measures

Primary Outcome Measures

Pharmacokinetic parameter "Cmax" [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)" [Changes from baseline to study days 1,2,3,4]
Dose-dependent changes in AUC of several doses of RE02.
Pharmacokinetic parameter "T1/2" [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 [On study days 1,2,3,4]
Dose-dependent changes in incidence of adverse drug reactions
Blood count (Lab biochemistry) [Changes from baseline to End of Study, an average of 4 weeks]
Changes from baseline in blood count
Clinical chemistry (Lab biochemistry) [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) [Changes from baseline to End of Study, an average of 4 weeks]
Changes from baseline in blood coagulation
QT interval (12-lead Electrocardiogram [ECG]) [Changes from baseline to study days 1,2,3,4]
Dose-dependent changes of QT intervals assessed by clinical 12-lead ECG)
Blood pressure [Changes from baseline to study days 1,2,3,4]
Dose-dependent changes in systolic and diastolic blood pressure
Heart rate [Changes from baseline to study days 1,2,3,4]
Dose-dependent changes in heart rate
Temperature [Changes from baseline to study days 1,2,3,4]
Dose-dependent changes in temperature
Subjective effects [Changes from baseline to study days 1,2,3,4]
Dose-dependent changes in trajectories of subjective effects

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Reconnect Labs

Investigators

Principal Investigator: Erich Seifritz, Prof, University Hospital of Psychiatry Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Reconnect Labs

ClinicalTrials.gov Identifier:

NCT05979727

Other Study ID Numbers:

MEO-DMT-VR

First Posted:

Aug 7, 2023

Last Update Posted:

Aug 7, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 7, 2023