Pharmacokinetics in Healthy AdultsPhase 1NCT05032833
Single Ascending Dose Study With 5-MeO-DMT in Healthy Subjects
A Phase 1 study testing 5-MeO-DMT 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 5-MeO-DMT 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?
- 5-MeO-DMT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Sep 2021to 7 Jul 2022
- 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 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
The study will evaluate safety, tolerability and PK profile of 5-MeO-DMT in healthy subjects
- Conditions
- Pharmacokinetics in Healthy Adults
- Being tested
- 5-MeO-DMT, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-MeO-DMTDrug
A single dose of 5-MeO-DMT will be administered intranasally
PlaceboOther
A single dose of placebo will be administered intranasally
| Study group | Role | What they receive |
|---|---|---|
| 5-MeO-DMT arm | Experimental | Not described Receives: Drug: 5-MeO-DMT |
| 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 posted2 Sep 2021
- Study start22 Sep 2021
- Primary completion7 Jul 2022
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beckley Psytech Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032833
- Sponsor's protocol ID
- BPL-5MEO-101
- Status last verified
- Oct 2022
- First submitted
- 24 Aug 2021
- Last updated
- 12 Oct 2022
- 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05032833
- Acronym / sponsor ID
- BPL-5MEO-101
- Conditions
- Pharmacokinetics in Healthy Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Beckley Psytech LimitedIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 2 Sep 2021 (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 5-MeO-DMT 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 |
|---|---|---|
| 5-MeO-DMT arm | Experimental | Drug: 5-MeO-DMT |
| 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 |
|---|---|---|
| 5-MeO-DMTA single dose of 5-MeO-DMT will be administered intranasally | Drug | 5-MeO-DMT 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 12 Oct 2022.
- 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
Related trials for Pharmacokinetics in Healthy Adults
RecruitingPhase 1
A Clinical Trial of MK-1406 in Healthy Participants (MK-1406-008)
Healthy
Not yet recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-08161842 Are Tolerated and Act in the Body in Healthy and Older Adults
Alzheimer Disease
RecruitingPhase 1
Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HTX-001
Nonobstructive Hypertrophic Cardiomyopathy
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
RecruitingPhase 1
A Study to See How Safe a New Medicine (NNC0642-1895) is in Healthy People
Healthy Volunteers
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.
The record lists no contact. Use the official record to reach the sponsor.
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 5-MeO-DMT 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 12 Oct 2022. 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?
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 12 Oct 2022.