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

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ClinicalTrials.gov Identifier: NCT05032833
Recruitment Status : Recruiting
First Posted : September 2, 2021
Last Update Posted : September 21, 2021
Sponsor:
Information provided by (Responsible Party):
Beckley Psytech Limited

Tracking Information
First Submitted Date  ICMJE August 24, 2021
First Posted Date  ICMJE September 2, 2021
Last Update Posted Date September 21, 2021
Estimated Study Start Date  ICMJE September 2021
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2021)
Percentage of subjects with treatment emergent AEs (TEAES) [ Time Frame: From screening through to the follow up visit, up to 65 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 27, 2021)
Percentage of patients with treatment emergent AEs (TEAES) [ Time Frame: From screening through to the follow up visit, up to 65 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2021)
  • Peak plasma concentration (Cmax) [ Time Frame: Day 1 (dosing day) and Day 2 ]
  • Time to reach Cmax (tmax) [ Time Frame: Day 1 (dosing day) and Day 2 ]
  • Area under the plasma concentration- time curve [ Time Frame: Day 1 (dosing day) and Day 2 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single Ascending Dose Study With 5-MeO-DMT in Healthy Subjects
Official Title  ICMJE 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
Brief Summary The study will evaluate safety, tolerability and PK profile of 5-MeO-DMT in healthy subjects
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pharmacokinetics in Healthy Adults
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 5-MeO-DMT arm
    Intervention: Drug: 5-MeO-DMT
  • Placebo Comparator: Placebo arm
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 27, 2021)
42
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Research Assistant 0203 299 1851/1852 5-MeO-DMT@kcl.ac.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05032833
Other Study ID Numbers  ICMJE BPL-5MEO-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Due to the UK GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion
Responsible Party Beckley Psytech Limited
Study Sponsor  ICMJE Beckley Psytech Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Beckley Psytech Limited
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP