Pharmacokinetics in Healthy Adults Clinical Trial
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
Verified date | October 2022 |
Source | Beckley Psytech Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study will evaluate safety, tolerability and PK profile of 5-MeO-DMT in healthy subjects
Status | Completed |
Enrollment | 36 |
Est. completion date | July 7, 2022 |
Est. primary completion date | July 7, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 25 Years to 55 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | King's College London | London |
Lead Sponsor | Collaborator |
---|---|
Beckley Psytech Limited |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of subjects with treatment emergent AEs (TEAES) | From screening through to the follow up visit, up to 65 days | ||
Secondary | Peak plasma concentration (Cmax) | Day 1 (dosing day) and Day 2 | ||
Secondary | Time to reach Cmax (tmax) | Day 1 (dosing day) and Day 2 | ||
Secondary | Area under the plasma concentration- time curve | Day 1 (dosing day) and Day 2 |
Status | Clinical Trial | Phase | |
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Completed |
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