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Single Ascending Dose Study With 5-MeO-DMT in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05032833
Recruitment Status : Recruiting
First Posted : September 2, 2021
Last Update Posted : April 4, 2022
Sponsor:
Information provided by (Responsible Party):
Beckley Psytech Limited

Study Description
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Brief Summary:
The study will evaluate safety, tolerability and PK profile of 5-MeO-DMT in healthy subjects

Condition or disease Intervention/treatment Phase
Pharmacokinetics in Healthy Adults Drug: 5-MeO-DMT Other: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Phase 1, First-in-Human, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of Intranasal 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) in Healthy Subjects
Actual Study Start Date : September 22, 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: 5-MeO-DMT arm Drug: 5-MeO-DMT
A single dose of 5-MeO-DMT will be administered intranasally
Placebo Comparator: Placebo arm Other: Placebo
A single dose of placebo will be administered intranasally


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of subjects with treatment emergent AEs (TEAES) [ Time Frame: From screening through to the follow up visit, up to 65 days ]

Secondary Outcome Measures :
  1. Peak plasma concentration (Cmax) [ Time Frame: Day 1 (dosing day) and Day 2 ]
  2. Time to reach Cmax (tmax) [ Time Frame: Day 1 (dosing day) and Day 2 ]
  3. Area under the plasma concentration- time curve [ Time Frame: Day 1 (dosing day) and Day 2 ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

* Medically healthy based on medical records and study specific assessments

Exclusion Criteria:

* Presence or history of severe adverse reaction to any drug or drug excipient

Contacts and Locations
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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): NCT05032833


Contacts
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Contact: Research Assistant 0203 299 1851/1852 5-MeO-DMT@kcl.ac.uk

Locations
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United Kingdom
King's College London Recruiting
London, United Kingdom
Contact: James Rucker, MRCPsych         
Sponsors and Collaborators
Beckley Psytech Limited
More Information
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Responsible Party: Beckley Psytech Limited
ClinicalTrials.gov Identifier: NCT05032833    
Other Study ID Numbers: BPL-5MEO-101
First Posted: September 2, 2021    Key Record Dates
Last Update Posted: April 4, 2022
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Due to the UK GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No