Single Ascending Dose Study With 5-MeO-DMT in Healthy Subjects
Sponsor
Beckley Psytech Limited (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05032833
Collaborator
(none)
51
1
2
9.3
5.5
Study Details
Study Description
Brief Summary
The study will evaluate safety, tolerability and PK profile of 5-MeO-DMT in healthy subjects
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Anticipated 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
:
Sep 22, 2021
Anticipated Primary Completion Date
:
Jul 1, 2022
Anticipated Study Completion Date
:
Jul 1, 2022
Arms and Interventions
| 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
Primary Outcome Measures
- Percentage of subjects with treatment emergent AEs (TEAES) [From screening through to the follow up visit, up to 65 days]
Secondary Outcome Measures
- Peak plasma concentration (Cmax) [Day 1 (dosing day) and Day 2]
- Time to reach Cmax (tmax) [Day 1 (dosing day) and Day 2]
- Area under the plasma concentration- time curve [Day 1 (dosing day) and Day 2]
Eligibility Criteria
Criteria
Ages Eligible for Study:
25 Years
to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | King's College London | London | United Kingdom |
Sponsors and Collaborators
- Beckley Psytech Limited
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Beckley Psytech Limited
ClinicalTrials.gov Identifier:
NCT05032833
Other Study ID Numbers:
- BPL-5MEO-101
First Posted:
Sep 2, 2021
Last Update Posted:
Apr 4, 2022
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No