Pharmacokinetics in Healthy AdultsPhase 1NCT05347849
Single Ascending Dose Study With BPL-003 in Healthy Subjects
A Phase 1 study testing BPL-003 in people with Pharmacokinetics in Healthy Adults, run by Beckley Psytech Limited at 1 site in United Kingdom.
Trial summary
The study will evaluate safety, tolerability and PK profile of BPL-003 in healthy subjects Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics in Healthy Adults
- What is being tested?
- BPL-003
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Feb 2022to 19 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically healthy based on medical records and study specific assessments
Who cannot join
- Presence or history of severe adverse reaction to any drug or drug excipient
Trial locations and contacts
1 site in 1 country.
About this study
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
The study will evaluate safety, tolerability and PK profile of BPL-003 in healthy subjects
- Conditions
- Pharmacokinetics in Healthy Adults
- Being tested
- BPL-003, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPL-003Drug
A single dose of BPL-003 will be administered intranasally
PlaceboOther
A single dose of placebo will be administered intranasally
| Study group | Role | What they receive |
|---|---|---|
| BPL-003 arm | Experimental | Not described Receives: Drug: BPL-003 |
| Placebo arm | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with treatment emergent AEs (TEAES)
Measured: From screening through to the follow up visit, up to 65 days
Secondary outcomes (3)
Peak plasma concentration (Cmax)
Measured: Day 1 (dosing day) and Day 2
Time to reach Cmax (tmax)
Measured: Day 1 (dosing day) and Day 2
Area under the plasma concentration- time curve
Measured: Day 1 (dosing day) and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start14 Feb 2022
- Primary completion19 Jan 2024
- Study completion19 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pharmacokinetics in Healthy AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beckley Psytech Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- VP & Head of Clinical Development, PhD, Study director, Beckley Psytech Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347849
- Sponsor's protocol ID
- BPL-003-103
- Status last verified
- Mar 2024
- First submitted
- 21 Apr 2022
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the UK GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion
Publications
Rucker JJ, Roberts C, Seynaeve M, Young AH, Suttle B, Yamamoto T, Ermakova AO, Dunbar F, Wiegand F. Phase 1, placebo-controlled, single ascending dose trial to evaluate the safety, pharmacokinetics and effect on altered states of consciousness of intranasal BPL-003 (5-methoxy-N,N-dimethyltryptamine benzoate) in healthy participants. J Psychopharmacol. 2024 Aug;38(8):712-723. doi: 10.1177/02698811241246857. Epub 2024 Apr 14.
PubMed 38616411
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05347849
- Acronym / sponsor ID
- BPL-003-103
- Conditions
- Pharmacokinetics in Healthy Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Beckley Psytech LimitedIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 19 Jan 2024 (actual)
- Study completion
- 19 Jan 2024 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate safety, tolerability and PK profile of BPL-003 in healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPL-003 arm | Experimental | Drug: BPL-003 |
| Placebo arm | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Medically healthy based on medical records and study specific assessments
Key exclusion criteria (1 listed)
- Presence or history of severe adverse reaction to any drug or drug excipient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BPL-003A single dose of BPL-003 will be administered intranasally | Drug | BPL-003 arm |
| PlaceboA single dose of placebo will be administered intranasally | Other | Placebo arm |
Primary outcome
Percentage of subjects with treatment emergent AEs (TEAES)
Time frame: From screening through to the follow up visit, up to 65 days
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Derived from this study: PubMed 38616411Rucker JJ, Roberts C, Seynaeve M, Young AH, Suttle B, Yamamoto T, Ermakova AO, Dunbar F, Wiegand F. Phase 1, placebo-controlled, single ascending dose trial to evaluate the safety, pharmacokinetics and effect on altered states of consciousness of intranasal BPL-003 (5-methoxy-N,N-dimethyltryptamine benzoate) in healthy participants. J Psychopharmacol. 2024 Aug;38(8):712-723. doi: 10.1177/02698811241246857. Epub 2024 Apr 14.
- Individual participant dataSharing planned: No. Due to the UK GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
VP & Head of Clinical Development, PhD study director
Beckley Psytech Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BPL-003 in people with Pharmacokinetics in Healthy Adults, run by Beckley Psytech Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with treatment emergent AEs (TEAES) (time frame: From screening through to the follow up visit, up to 65 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05347849, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024; AzTrials last refreshed its copy on 3 Nov 2026.