SPL026 (DMT Fumarate) in Healthy Subjects and MDD Patients

NCT04673383 | Completed Phase 1 DMC

• 1 other identifier: CT026_001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

SPL026 (N,N-dimethyltryptamine \[DMT\] fumarate) is a psychedelic tryptamine being developed as a therapy for patients with major depressive disorder (MDD).

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability in healthy volunteers

  Safety and tolerability measured by lab biochemistry, adverse events and intensity rating scale to measure tolerability of the psychedelic experience

  Up to three months after a single dose

• Efficacy of SPL026 in MDD patients with moderate to severe depression

  Montgomery-Åsberg Depression Rating Scale (MADRS) score (where 7 - 19 is mild depression, 20 - 34 is moderate depression, and \>34 is severe depression) change from baseline at 2 weeks after the first dose (± 2 days)

  2 weeks after a single dose

Study Arms (4)

Healthy volunteers (active)

EXPERIMENTAL

SPL026 to be administered by IV injection

Drug: SPL026

Healthy volunteers (placebo)

EXPERIMENTAL

SPL026-matched placebo to be administered by IV injection

Drug: Placebo

Patients (active)

EXPERIMENTAL

SPL026 to be administered by IV injection

Drug: SPL026

Patients (placebo)

EXPERIMENTAL

SPL026-matched placebo to be administered by IV injection

Drug: Placebo

Interventions

SPL026 DRUG

Intravenous solution

Also known as: DMT, dimethyltryptamine, n,n-dimethytryptaimine

Healthy volunteers (active); Patients (active)

Placebo DRUG

SPL026-matched placebo

Also known as: Dummy, SPL026-matched placebo

Healthy volunteers (placebo); Patients (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Small Pharma Ltd: lead

Study Sites (2)

MAC Clinical Research

Liverpool, L34 1BH, United Kingdom

Location

Hammersmith Medicines Research

London, United Kingdom

Location

Related Publications (2)

• Good M, Joel Z, Benway T, Routledge C, Timmermann C, Erritzoe D, Weaver R, Allen G, Hughes C, Topping H, Bowman A, James E. Pharmacokinetics of N,N-dimethyltryptamine in Humans. Eur J Drug Metab Pharmacokinet. 2023 May;48(3):311-327. doi: 10.1007/s13318-023-00822-y. Epub 2023 Apr 22.

  PMID: 37086340 RESULT

• James E, Erritzoe D, Benway T, Joel Z, Timmermann C, Good M, Agnorelli C, Weiss BM, Barba T, Campbell G, Baker Jones M, Hughes C, Topping H, Boyce M, Routledge C. Safety, tolerability, pharmacodynamic and wellbeing effects of SPL026 (dimethyltryptamine fumarate) in healthy participants: a randomized, placebo-controlled phase 1 trial. Front Psychiatry. 2024 Jan 11;14:1305796. doi: 10.3389/fpsyt.2023.1305796. eCollection 2023.

  PMID: 38274414 RESULT

Related Links

• Clinical Trial Report Synopsis Available Here

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

N,N-Dimethyltryptamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• David Erritzoe, MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

• Malcolm Boyce, MD

  Hammersmith Medicines Research

  PRINCIPAL INVESTIGATOR

• Fabian Devlin, MD

  MAC Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: RCT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 17, 2020
• Study Start: February 4, 2021
• Primary Completion: October 1, 2022
• Study Completion: December 22, 2022
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)