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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05032833
Other study ID # BPL-5MEO-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 22, 2021
Est. completion date July 7, 2022

Study information

Verified date October 2022
Source Beckley Psytech Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date July 7, 2022
Est. primary completion date July 7, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Pharmacokinetics in Healthy Adults

Intervention

Drug:
5-MeO-DMT
A single dose of 5-MeO-DMT will be administered intranasally
Other:
Placebo
A single dose of placebo will be administered intranasally

Locations

Country Name City State
United Kingdom King's College London London

Sponsors (1)

Lead Sponsor Collaborator
Beckley Psytech Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of subjects with treatment emergent AEs (TEAES) From screening through to the follow up visit, up to 65 days
Secondary Peak plasma concentration (Cmax) Day 1 (dosing day) and Day 2
Secondary Time to reach Cmax (tmax) Day 1 (dosing day) and Day 2
Secondary Area under the plasma concentration- time curve Day 1 (dosing day) and Day 2
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