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

October 10, 2022 updated by: Beckley Psytech Limited

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

The study will evaluate safety, tolerability and PK profile of 5-MeO-DMT in healthy subjects

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo arm
Other: Placebo
A single dose of placebo will be administered intranasally
Experimental: 5-MeO-DMT arm
Drug: 5-MeO-DMT
A single dose of 5-MeO-DMT will be administered intranasally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects with treatment emergent AEs (TEAES)
Time Frame: From screening through to the follow up visit, up to 65 days
From screening through to the follow up visit, up to 65 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Peak plasma concentration (Cmax)
Time Frame: Day 1 (dosing day) and Day 2
Day 1 (dosing day) and Day 2
Time to reach Cmax (tmax)
Time Frame: Day 1 (dosing day) and Day 2
Day 1 (dosing day) and Day 2
Area under the plasma concentration- time curve
Time Frame: Day 1 (dosing day) and Day 2
Day 1 (dosing day) and Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beckley Psytech Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2021

Primary Completion (Actual)

July 7, 2022

Study Completion (Actual)

July 7, 2022

Study Registration Dates

First Submitted

August 24, 2021

First Submitted That Met QC Criteria

August 27, 2021

First Posted (Actual)

September 2, 2021

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 10, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • BPL-5MEO-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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