Assessment of Single Doses of Oral Dexanabinol in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of Safety, Tolerability and Pharmacokinetics of Single Doses of Oral Dexanabinol in Healthy Subjects

Conditions
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Safety, Tolerability, Pharmacokinetics, Cancer

Intervention / Treatment
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* Drug: Dexanabinol Dose Level 1
* Drug: Dexanabinol Dose Level 2
* Drug: Dexanabinol Dose Level 3
* Drug: Dexanabinol Dose Level 4
* Drug: Dexanabinol Dose Level 5
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males aged 18 to 45 years Body mass index 18.0 to 32.0 kg/m2, or if outside the range, considered not clinically significant by the investigator Exclusion Criteria: Participation in a clinical research study within the previous 3 months Current smokers and those who have smoked within the last 12 months History of any drug or alcohol abuse in the past 2 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexanabinol Dose Level 1<br>Single oral dose of dexanabinol | Drug: Dexanabinol Dose Level 1<br>* Oral formulation of dexanabinol<br>* Other names: ETS2101;|
| Experimental: Dexanabinol Dose Level 2<br>Single oral dose of dexanabinol | Drug: Dexanabinol Dose Level 2<br>* Oral formulation of dexanabinol<br>* Other names: ETS2101;|
| Experimental: Dexanabinol Dose Level 3<br>Single oral dose of dexanabinol | Drug: Dexanabinol Dose Level 3<br>* Oral formulation of dexanabinol<br>* Other names: ETS2101;|
| Experimental: Dexanabinol Dose Level 4<br>Single oral dose of dexanabinol | Drug: Dexanabinol Dose Level 4<br>* Oral formulation of dexanabinol<br>* Other names: ETS2101;|
| Experimental: Dexanabinol Dose Level 5<br>Single oral dose of dexanabinol | Drug: Dexanabinol Dose Level 5<br>* Oral formulation of dexanabinol<br>* Other names: ETS2101;|
| Placebo Comparator: Placebo<br>Single oral dose of matching placebo | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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: Physical exam Safety bloods and urinalysis 12-lead ECG Vital signs | Participants will be followed until follow up visit, 6-11 days after dosing | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexanabinol, Oral, Safety, Tolerability, Pharmacokinetics