Single Ascending Dose Study With 5-MeO-DMT in Healthy Sub... | NCT05032833

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

NCT05032833

Sponsor

Beckley Psytech Limited

Status

Completed

Last Update Posted

Oct 12, 2022Actual

Enrollment

36Actual

Phase

Phase 1

Conditions

Pharmacokinetics in Healthy Adults

Interventions

5-MeO-DMT
Placebo

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 22, 2021Actual

Primary Completion Date

Jul 7, 2022Actual

Completion Date

Jul 7, 2022Actual

First Submitted Date

Aug 24, 2021

First Submission Date that Met QC Criteria

Aug 27, 2021

First Posted Date

Sep 2, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2022

Last Update Posted Date

Oct 12, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
5-MeO-DMT arm	Experimental		Drug: 5-MeO-DMT
Placebo arm	Placebo Comparator		Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
5-MeO-DMT	Drug	A single dose of 5-MeO-DMT will be administered intranasally	5-MeO-DMT arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
King's College London		London			United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Due to the UK GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008732	Methoxydimethyltryptamines

Ancestor Terms

ID	Term
D004130	N,N-Dimethyltryptamine
D014363	Tryptamines
D015306	Biogenic Monoamines
D001679	Biogenic Amines

Browse Leaves

Not provided

Browse Branches

Not provided