A double-blind, randomised, placebo-controlled study to evaluate the pharmacokinetics, safety and pharmacodynamics of ascending single and fixed repeat intravenous doses of DMT in healthy subjects
- Conditions
- Stroke10007963
- Registration Number
- NL-OMON51817
- Lead Sponsor
- Algernon Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Normotensive male or female volunteers, deemed healthy on the basis of a
clinical history, physical examination, ECG, vital signs, and laboratory tests
of blood and urine; agree to follow the contraception requirements of the
trial; able to give fully informed written consent.
Positive tests for hepatitis B & C, HIV; severe adverse reaction to any drug;
history of adverse (psychological) reaction to DMT or other serotonergic
psychedelic drugs; drug or alcohol abuse; use of over-the-counter medication
(with the exception of common analgesics, eg paracetamol [acetaminophen] or
ibuprofen) or receipt of coronavirus disease 2019 (COVID 19) vaccination during
the 7 days before the first dose of trial medication, or use of prescribed
medication during the 14 days before first dose of trial medication, or
monoamine oxidase inhibitors (MAOI) during the 30 days before the first dose of
trial medication; participation in other clinical trials of unlicensed
medicines, or loss of more than 400 mL blood, within the previous 90 days;
vital signs outside the acceptable range; positive urine drug test; clinically
relevant abnormal findings at the screening assessment; acute or chronic
illness; significant suicide risk identified from the C SSRS, previous suicidal
behaviour/ideation, or clinical assessment; clinically relevant abnormal
medical history or concurrent medical condition (including psychotic or seizure
disorders); close (first and second degree) relative with schizophrenia
spectrum or other psychotic, bipolar or related disorder; persistent
psychological effects following the previous use of psychedelics; possibility
that volunteer will not cooperate; pre-menopausal women who are pregnant or
lactating, or are sexually active and not using a reliable method of
contraception.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety and tolerability: Vital signs (heart rate, blood pressure, respiratory<br /><br>rate and temperature), 12-lead electrocardiograms (ECGs), physical examination,<br /><br>laboratory safety tests (haematology, clinical chemistry, coagulation, and<br /><br>urinalysis), local tolerability at infusion site, Columbia-Suicide Severity<br /><br>Rating Scale (C SSRS), occurrence of psychotic symptoms (BPRS), occurrence of<br /><br>central 5-HT toxicity (Hunters criteria + CPK)and adverse events (AEs).</p><br>
- Secondary Outcome Measures
Name Time Method <p>PK: Cmax, tmax, AUClast, AUC0-t, AUCinf, %AUCextrap, t*, CL, Vss, Vz, MRTinf,<br /><br>and *z of DMT.</p><br>