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The purpose of this study is to test the safety and observe the pharmacokinetics (distribution and elimination of the drug) of the compound dexanabinol (ETS2101) in healthy male subjects following a single oral dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexanabinol Dose Level 1 | Experimental | Single oral dose of dexanabinol |
|
| Dexanabinol Dose Level 2 | Experimental | Single oral dose of dexanabinol |
|
| Dexanabinol Dose Level 3 | Experimental | Single oral dose of dexanabinol |
|
| Dexanabinol Dose Level 4 | Experimental | Single oral dose of dexanabinol |
|
| Dexanabinol Dose Level 5 | Experimental | Single oral dose of dexanabinol |
|
| Placebo | Placebo Comparator | Single oral dose of matching placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexanabinol Dose Level 1 | Drug | Oral formulation of dexanabinol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability Based on the Number of Participants With Adverse Events and Comparison of Baseline and Post Dose Parameters | Safety and tolerability based on the number of participants with adverse events. Assessment and comparison to baseline of the following:
| Participants will be followed until follow up visit, 6-11 days after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve of the Compound Dexanabinol (ETS2101) From Pre-dose up to 48 Hours Post Dose | Pharmacokinetic parameters will be assessed in a blinded fashion at the end of each cohort, prior to dose escalation. | Pre-dose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16,24,36,48 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic Biomarker Assessment | Blood samples taken and analysed for the purposes of the identification and quantification of pharmacodynamic biomarkers pre-dose and at several points after dosing. | Pre-dose, 1, 6 and 24 hours post dose |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Evans, MD | Quotient Clinical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Clinical | Nottingham | Nottinghamshire | NG11 6JS | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexanabinol Dose Level 1 | Single oral dose of dexanabinol at Dose Level 1 Dexanabinol: Oral formulation of dexanabinol |
| FG001 | Dexanabinol Dose Level 2 | Single oral dose of dexanabinol at Dose level 2 Dexanabinol: Oral formulation of dexanabinol |
| FG002 | Dexanabinol Dose Level 3 | Single oral dose of dexanabinol at Dose level 3 Dexanabinol: Oral formulation of dexanabinol |
| FG003 | Dexanabinol Dose Level 4 | Single oral dose of dexanabinol at Dose level 4 Dexanabinol: Oral formulation of dexanabinol |
| FG004 | Dexanabinol Dose Level 5 | Single oral dose of dexanabinol at Dose level 5 Dexanabinol: Oral formulation of dexanabinol |
| FG005 | Placebo | Single oral dose of matching placebo Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Healthy male subjects between 18 and 45 years of age with a body mass index between 18.0 and 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexanabinol | Single oral dose of dexanabinol Dexanabinol: Oral formulation of dexanabinol |
| BG001 | Placebo | Single oral dose of matching placebo Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety and Tolerability Based on the Number of Participants With Adverse Events and Comparison of Baseline and Post Dose Parameters | Safety and tolerability based on the number of participants with adverse events. Assessment and comparison to baseline of the following:
| Posted | Number | participants | Participants will be followed until follow up visit, 6-11 days after dosing |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexanabinol Dose Level 1 | Single oral dose of dexanabinol Dexanabinol: Oral formulation of dexanabinol |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations Manager | e-Therapeutics Plc | +44 1993 880000 | contact@etherapeutics.co.uk |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Dexanabinol Dose Level 2 | Drug | Oral formulation of dexanabinol |
|
|
| Dexanabinol Dose Level 3 | Drug | Oral formulation of dexanabinol |
|
|
| Dexanabinol Dose Level 4 | Drug | Oral formulation of dexanabinol |
|
|
| Dexanabinol Dose Level 5 | Drug | Oral formulation of dexanabinol |
|
|
| Placebo | Drug |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Area Under the Curve of the Compound Dexanabinol (ETS2101) From Pre-dose up to 48 Hours Post Dose | Pharmacokinetic parameters will be assessed in a blinded fashion at the end of each cohort, prior to dose escalation. | Posted | Mean | Standard Deviation | ng.h/mL | Pre-dose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16,24,36,48 hours post dose |
|
|
|
| Other Pre-specified | Pharmacodynamic Biomarker Assessment | Blood samples taken and analysed for the purposes of the identification and quantification of pharmacodynamic biomarkers pre-dose and at several points after dosing. | Not Posted | Pre-dose, 1, 6 and 24 hours post dose |
| 0 |
| 6 |
| 3 |
| 6 |
| EG001 | Dexanabinol Dose Level 2 | Single oral dose of dexanabinol Dexanabinol: Oral formulation of dexanabinol | 0 | 6 | 1 | 6 |
| EG002 | Dexanabinol Dose Level 3 | Single oral dose of dexanabinol Dexanabinol: Oral formuulation of dexanabinol | 0 | 6 | 1 | 6 |
| EG003 | Dexanabinol Dose Level 4 | Single oral dose of dexanabinol Dexanabinol: Oral formulation of dexanabinol | 0 | 6 | 3 | 6 |
| EG004 | Dexanabinol Dose Level 5 | Single oral dose of dexanabinol Dexanabinol: Oral formulation of dexanabinol | 0 | 6 | 1 | 6 |
| EG005 | Placebo | Single oral dose of matching placebo Placebo | 0 | 10 | 1 | 10 |
| Abdominal pain | Gastrointestinal disorders |
|
| Lower respiratory tract infection | Infections and infestations |
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| Acute otitis media | Infections and infestations |
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| Pyelonephritis | Infections and infestations |
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| Rhinitis | Infections and infestations |
|
| Upper respiratory tract infection | Infections and infestations |
|
| Back pain | Musculoskeletal and connective tissue disorders |
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| Musculo-skeletal stiffness | Musculoskeletal and connective tissue disorders |
|
| Myalgia | Musculoskeletal and connective tissue disorders |
|
| Headache | Nervous system disorders |
|
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