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OpenTrials
Completed

NCT Number: NCT05032833

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

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

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Key information

Conditions

Pharmacokinetics in Healthy Adults

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

King's College London

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5-MeO-DMT

Drug

A single dose of 5-MeO-DMT will be administered intranasally

Placebo

Other

A single dose of placebo will be administered intranasally

Primary outcomes

  1. Percentage of subjects with treatment emergent AEs (TEAES)

    Time frame: From screening through to the follow up visit, up to 65 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Beckley Psytech Limited

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 2, 2021
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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