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SPL026 (DMT Fumarate) in Healthy Subjects and MDD Patients

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ClinicalTrials.gov Identifier: NCT04673383
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Small Pharma Ltd

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: SPL026 Drug: Placebo Phase 1 Phase 2

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-escalation parallel group study.

Patients will receive up to 2 single doses of SPL026, 2 weeks apart. Dose 1 will be randomised double-blind with placebo. Dose 2 will be open label, active SPL026.

SPL026 will be administered by IV injection. Safety and tolerability, PK, PD and efficacy will be measured.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: RCT
Primary Purpose: Treatment
Official Title: A Double-blind, Randomised, Placebo-controlled Study of Intravenous Doses of SPL026 (DMT Fumarate), a Serotonergic Psychedelic, in Healthy Subjects (Part A) and Patients With Major Depressive Disorder (Part B)
Actual Study Start Date : February 4, 2021
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Healthy volunteers (active)
SPL026 to be administered by IV injection
Drug: SPL026
Intravenous solution
Other Names:
  • DMT
  • dimethyltryptamine
  • n,n-dimethytryptaimine

Experimental: Healthy volunteers (placebo)
SPL026-matched placebo to be administered by IV injection
Drug: Placebo
SPL026-matched placebo
Other Names:
  • Dummy
  • SPL026-matched placebo

Experimental: Patients (active)
SPL026 to be administered by IV injection
Drug: SPL026
Intravenous solution
Other Names:
  • DMT
  • dimethyltryptamine
  • n,n-dimethytryptaimine

Experimental: Patients (placebo)
SPL026-matched placebo to be administered by IV injection
Drug: Placebo
SPL026-matched placebo
Other Names:
  • Dummy
  • SPL026-matched placebo




Primary Outcome Measures :
  1. Safety and tolerability in healthy volunteers [ Time Frame: Up to three months after a single dose ]
    Safety and tolerability measured by lab biochemistry, adverse events and intensity rating scale to measure tolerability of the psychedelic experience

  2. Efficacy of SPL026 in MDD patients with moderate to severe depression [ Time Frame: 2 weeks after a single dose ]
    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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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 Criteria:

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04673383


Contacts
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Contact: Ellen H James, PhD 0044 20 3371 8533 ellen.james@smallpharma.co.uk
Contact: Carol Routledge, PhD carol.routledge@smallpharma.co.uk

Locations
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United Kingdom
Hammersmith Medicines Research Recruiting
London, United Kingdom
Contact: Malcolm Boyce, MD         
Sponsors and Collaborators
Small Pharma Ltd
Investigators
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Study Director: Jan Steiner, MD Oxford Therapeutics Consulting
Principal Investigator: David Erritzoe, MD Imperial College London
Principal Investigator: Malcolm Boyce, MD Hammersmith Medicines Research
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Responsible Party: Small Pharma Ltd
ClinicalTrials.gov Identifier: NCT04673383    
Other Study ID Numbers: CT026_001
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan for this yet.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
N,N-Dimethyltryptamine
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Receptor Agonists