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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000150-29 | EudraCT Number |
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| Name | Class |
|---|---|
| Beckley Psytech Limited | INDUSTRY |
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A study to assess the safety and tolerability of a drug called ELE-101 and see how the body absorbs and removes the drug and how it affects the body in healthy adult participants (Part 1) and in patients with depression (Part 2).
This is a 2-part study. Part 1 is a phase I, double-blind, placebo-controlled, randomized study to assess the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamic (PD) and subjective drug intensity (SDI) of single ascending intravenous (IV) doses of ELE-101 in healthy male and female adult participants. Part 2 is a Phase IIa, open-label study to evaluate a range of pharmacodynamic effects of a single intravenous dose of ELE-101 in patients with depression.
Healthy participants will receive either ELE-101 or placebo as an IV infusion in Part 1 and patients with MDD will receive ELE-101 as an IV infusion in Part 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (Part 1) | Experimental | A single 10-minute intravenous infusion of 0.25 mg ELE-101 or placebo (randomized as 6 active and 2 placebo) |
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| Cohort 2 (Part 1) | Experimental | A single 10-minute intravenous infusion of 0.75 mg ELE-101 or placebo (randomized as 6 active and 2 placebo) |
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| Cohort 3 (Part 1) | Experimental | A single 10-minute intravenous infusion of 2.0 mg ELE-101 or placebo (randomized as 6 active and 2 placebo) |
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| Cohort 4 (Part 1) | Experimental | A single TBD minute intravenous infusion of TBD mg ELE-101 or placebo (randomized as 6 active and 2 placebo) |
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| Cohort 5 (Part 1) | Experimental | A single TBD minute intravenous infusion of TBD mg ELE-101 or placebo (randomized as 6 active and 2 placebo) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELE-101 | Drug | ELE-101 solution for intravenous infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Percentage of participants with at least one safety event |
| Baseline up to Day 8 |
| Part 2: Subjective Drug Intensity Ratings | - The SDI questionnaire will be used to rate the real-time intensity of the psychedelic experience | pre-dose and at multiple time-points up to 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 and 2: Cmax: Maximum observed plasma concentration for ELE-101 and its metabolites | PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study | pre-dose and at multiple time-points up to 24 hours post-dose |
| Part 1 and 2: Tmax: Time to reach maximum plasma concentration (Cmax) for ELE-101 and its metabolites |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neel Bhatt | MAC Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MAC Clinical Research | Liverpool | L34 1BH | United Kingdom | |||
| MAC Clinical Research |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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Open label in Part 2
| Cohort 6 (Part 2) | Experimental | A single TBD minute intravenous infusion of TBD mg ELE-101 |
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| ELE-101 Placebo | Drug | ELE-101 placebo matching solution for intravenous infusion |
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PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study |
| pre-dose and at multiple time-points up to 24 hours post-dose |
| Part 1 and 2: AUCinf: Area under the plasma concentration-time curve from Time 0 to Infinity for ELE-101 and its metabolites | PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study | pre-dose and at multiple time-points up to 24 hours post-dose |
| Part 1 and 2: AUClast: Area under the plasma concentration-time curve from Time 0 to the time of the last quantifiable concentration for ELE-101 and its metabolites | PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study | pre-dose and at multiple time-points up to 24 hours post-dose |
| Part 1 and 2: AUC0-24: Area under the plasma concentration-time curve from Time 0 to 24 hours for ELE-101 and its metabolites | PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study | pre-dose and at multiple time-points up to 24 hours post-dose |
| Part 1 and 2: VZ: volume of distribution during the terminal disposition phase for ELE-101 and its metabolites | PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study | pre-dose and at multiple time-points up to 24 hours post-dose |
| Part 1 and 2: VZss: volume of distribution at steady state for ELE-101 and its metabolites | PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study | pre-dose and at multiple time-points up to 24 hours post-dose |
| Part 1 and 2: Cl: apparent total clearance from plasma for ELE-101 and its metabolites | PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study | pre-dose and at multiple time-points up to 24 hours post-dose |
| Part 1 and 2: MRTinf: mean residence time from Time 0 to Infinity for ELE-101 and its metabolites | PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study | pre-dose and at multiple time-points up to 24 hours post-dose |
| Part 1 and 2: t1/2: Terminal disposition phase half-life for ELE-101 and its metabolites | PK parameters in plasma will be calculated for psilocin and its primary metabolites throughout the study | pre-dose and at multiple time-points up to 24 hours post-dose |
| Part 1 and 2: Dischargeability: Assessment of subject-discharge readiness | The dischargeability evaluation will be based on Investigator judgement after review of participant safety data. | post-dose and 24 hours post-dose |
| Part 1: The dose related psychoactive effects of ELE-101 as evaluated by a Visual Analogue Scale | The Subjective Drug Intensity (SDI) is a Visual Analogue Scale scored from 0-10. | pre-dose and at multiple time-points up to 24 hours post-dose |
| Part 2: The effects of ELE-101 on the severity of depression evaluated by the Montgomery-Asberg Depression Rating Scale (MADRS) | The MADRS is a diagnostic questionnaire with ten items for measuring the severity of depressive episodes in patients with mood disorders. A higher MADRS score indicates more severe depression, and each item is scored from 0 to 6. The overall score ranges from 0 to 60. | Baseline up to Day 85 |
| Part 2: Percentage of participants with at least one safety event |
| Baseline up to Day 85 |
| Manchester |
| M13 9NQ |
| United Kingdom |
| D001519 |
| Behavior |