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Single Ascending Dose Study With BPL-003 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT05347849
Recruitment Status : Recruiting
First Posted : April 26, 2022
Last Update Posted : April 26, 2022
Sponsor:
Information provided by (Responsible Party):
Beckley Psytech Limited

Tracking Information
First Submitted Date  ICMJE April 21, 2022
First Posted Date  ICMJE April 26, 2022
Last Update Posted Date April 26, 2022
Actual Study Start Date  ICMJE February 14, 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2022)
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 Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2022)
  • 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 BPL-003 in Healthy Subjects
Official Title  ICMJE A Double-blind, Randomized, Phase 1, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of Intranasal BPL-003 (5-Methoxy-N,N-dimethyltryptamine Benzoate) in Healthy Subjects
Brief Summary The study will evaluate safety, tolerability and PK profile of BPL-003 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: BPL-003
    A single dose of BPL-003 will be administered intranasally
  • Other: Placebo
    A single dose of placebo will be administered intranasally
Study Arms  ICMJE
  • Experimental: BPL-003 arm
    Intervention: Drug: BPL-003
  • 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: April 21, 2022)
56
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 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
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05347849
Other Study ID Numbers  ICMJE BPL-003-103
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
Current Responsible Party Beckley Psytech Limited
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Beckley Psytech Limited
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Beckley Psytech Limited
Verification Date April 2022

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