Status:
COMPLETED
SPL026 (DMT Fumarate) in Healthy Subjects and MDD Patients
Lead Sponsor:
Small Pharma Ltd
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
SPL026 (N,N-dimethyltryptamine \[DMT\] fumarate) is a psychedelic tryptamine being developed as a therapy for patients with major depressive disorder (MDD).
Detailed Description
2-part study. Part A in psychedelic-naïve healthy volunteers. Part B in patients with MDD who score moderate-severe on Ham-D. Healthy volunteers will receive a single dose of SPL026 in a dose-escalat...
Eligibility Criteria
Inclusion
- Normotensive male or female, deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, laboratory tests of blood and urine, Mini-International Neuropsychiatric Interview (MINI) and Beck Scale for Suicidal Ideation (BSS); willing to follow the contraception requirements of the trial; willing to refrain from psychedelic drug use (excluding the study drug) during the trial and ≥ 3 months afterwards; willing to be contacted by email and video call, and have online access; able to give fully informed written consent. Part A only: psychedelic-naïve, ie have never taken a serotonergic psychedelic drug, in any form. Must be 25 years or older. Part B only: MDD diagnosis (as per DSM-V); not on antidepressant medication or willing to discontinue antidepressant medication (eg selective serotonin reuptake inhibitor \[SSRI\] treatment) for a sufficient time before and during the study; no psychedelic drug use in the 6 months before dosing.
Exclusion
- Pre-menopausal females who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception; clinically relevant abnormal findings at the screening assessment; acute or chronic illness (other than MDD \[Part B only\]) or infection; clinically relevant abnormal medical history or concurrent medical condition (other than MDD \[Part B only\]); positive tests for hepatitis B \& C, or HIV; severe adverse reaction to any drug; use of over-the-counter or prescribed medication (excluding oral contraceptives) within previous 28 days (paracetamol \[acetaminophen\] permitted up to 7 days, and antidepressant medication must have ceased for at least 14 days; 28 days for MOAIs) before first dose of trial medication; drug or alcohol abuse; use of cannabis in the 24 h before each study visit; heavy smokers (\> 10 \[Part A\] or \> 20 cigarettes \[Part B\] daily); supine blood pressure, heart rate, or QTcF outside the acceptable ranges; participation in other clinical trials of unlicensed medicines, or loss of more than 400 mL blood, within the previous 3 months; phobia of needles or blood; possibility that volunteer will not cooperate with the study.
Key Trial Info
Start Date :
February 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2022
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04673383
Start Date
February 4 2021
End Date
December 22 2022
Last Update
March 27 2024
Active Locations (2)
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1
MAC Clinical Research
Liverpool, United Kingdom, L34 1BH
2
Hammersmith Medicines Research
London, United Kingdom