Dose-finding PKPD Trial for RE02 in Healthy Subjects

NCT05979727 | Terminated Phase 1

• 1 other identifier: MEO-DMT-VR
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (12)

• Pharmacokinetic parameter "Cmax"

  Dose-dependent changes in Cmax of several doses of RE02

  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.

  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.

  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

  On study days 1,2,3,4

• Blood count (Lab biochemistry)

  Changes from baseline in blood count

  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.

  Changes from baseline to End of Study, an average of 4 weeks

• Blood coagulation (Lab biochemistry)

  Changes from baseline in blood coagulation

  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)

  Changes from baseline to study days 1,2,3,4

• Blood pressure

  Dose-dependent changes in systolic and diastolic blood pressure

  Changes from baseline to study days 1,2,3,4

• Heart rate

  Dose-dependent changes in heart rate

  Changes from baseline to study days 1,2,3,4

• Temperature

  Dose-dependent changes in temperature

  Changes from baseline to study days 1,2,3,4

• Subjective effects

  Dose-dependent changes in trajectories of subjective effects

  Changes from baseline to study days 1,2,3,4

Study Arms (4)

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

Interventions

RE02 DRUG

Low, medium or high dose of RE02

High dose of RE02; Low dose of RE02; Moderate dose of RE02

Manitol DRUG

Placebo Comparator

Placebo

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Reconnect Labs: lead

Study Sites (1)

University Hospital of Psychiatry Zurich

Zurich, Canton of Zurich, 8032, Switzerland

Location

MeSH Terms

Interventions

Mannitol

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Erich Seifritz, Prof

  University Hospital of Psychiatry Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 7, 2023
• Study Start: November 20, 2023
• Primary Completion: December 10, 2023
• Study Completion: December 10, 2023
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)