Single Ascending Dose Study With 5-MeO-DMT in Healthy Subjects
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
1 other identifier
interventional
36
1 country
1
Brief Summary
The study will evaluate safety, tolerability and PK profile of 5-MeO-DMT in healthy subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2021
CompletedFirst Posted
Study publicly available on registry
September 2, 2021
CompletedStudy Start
First participant enrolled
September 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2022
CompletedOctober 12, 2022
October 1, 2022
10 months
August 24, 2021
October 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of subjects with treatment emergent AEs (TEAES)
From screening through to the follow up visit, up to 65 days
Secondary Outcomes (3)
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
Study Arms (2)
5-MeO-DMT arm
EXPERIMENTALPlacebo arm
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- \* Medically healthy based on medical records and study specific assessments
You may not qualify if:
- \* Presence or history of severe adverse reaction to any drug or drug excipient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King's College London
London, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2021
First Posted
September 2, 2021
Study Start
September 22, 2021
Primary Completion
July 7, 2022
Study Completion
July 7, 2022
Last Updated
October 12, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share
Due to the UK GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion