Back to resultsSingle Ascending Dose Study With BPL-003 in Healthy Subjects
Primary Purpose
Pharmacokinetics in Healthy Adults
Status
Recruiting
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
BPL-003
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pharmacokinetics in Healthy Adults
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
Sites / Locations
- Hammersmith Medicines ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BPL-003 arm
Placebo arm
Arm Description
Outcomes
Primary Outcome Measures
Percentage of subjects with treatment emergent AEs (TEAES)
Secondary Outcome Measures
Peak plasma concentration (Cmax)
Time to reach Cmax (tmax)
Area under the plasma concentration- time curve
Full Information
NCT ID
NCT05347849
First Posted
April 21, 2022
Last Updated
September 15, 2023
Sponsor
Beckley Psytech Limited
1. Study Identification
Unique Protocol Identification Number
NCT05347849
Brief Title
Single Ascending Dose Study With BPL-003 in Healthy Subjects
Official Title
A Two-part 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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beckley Psytech Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study will evaluate safety, tolerability and PK profile of BPL-003 in healthy subjects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pharmacokinetics in Healthy Adults
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BPL-003 arm
Arm Type
Experimental
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BPL-003
Intervention Description
A single dose of BPL-003 will be administered intranasally
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
A single dose of placebo will be administered intranasally
Primary Outcome Measure Information:
Title
Percentage of subjects with treatment emergent AEs (TEAES)
Time Frame
From screening through to the follow up visit, up to 65 days
Secondary Outcome Measure Information:
Title
Peak plasma concentration (Cmax)
Time Frame
Day 1 (dosing day) and Day 2
Title
Time to reach Cmax (tmax)
Time Frame
Day 1 (dosing day) and Day 2
Title
Area under the plasma concentration- time curve
Time Frame
Day 1 (dosing day) and Day 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beckley Psytech Ltd
Phone
+44 (0)1865 987633
Email
Medinfo@beckleypsytech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer, MD, PhD
Organizational Affiliation
Beckley Psytech Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Hammersmith Medicines Research
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+44 (0)20 8961 4130
Email
REC@hmrlondon.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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
Learn more about this trial
Single Ascending Dose Study With BPL-003 in Healthy Subjects
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