Anti-Arrhythmia Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

All Drugs and Chemicals

Analgesics

Psychotropic Drugs

HU 211

Dronabinol

Excitatory Amino Acid Antagonists

Neurotransmitter Agents

Protective Agents

Hallucinogens

Analgesics, Non-Narcotic

Hormones

Hormone Antagonists

Dexanabinol Dose Level 1

Dexanabinol Dose Level 2

Dexanabinol Dose Level 3

Dexanabinol Dose Level 4

Dexanabinol Dose Level 5

Placebo

Philip Evans, MD

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.

Assessment of Single Doses of Oral Dexanabinol in Healthy Subjects

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

Blood samples taken and analysed for the purposes of the identification and quantification of pharmacodynamic biomarkers pre-dose and at several points after dosing.

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

Pharmacokinetic parameters will be assessed in a blinded fashion at the end of each cohort, prior to dose escalation.

e-Therapeutics PLC

Single oral dose of dexanabinol

Dexanabinol: Oral formulation of dexanabinol

Single oral dose of dexanabinol

Dexanabinol: Oral formuulation of dexanabinol

Single oral dose of matching placebo

Placebo

Dexanabinol

Total

Age, Continuous

Sex: Female, Male

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.

Clinical Operations Manager

Safety and Tolerability Based on the Number of Participants With Adverse Events and Comparison of Baseline and Post Dose Parameters

Dose Level 2

Dose Level 3

Dose Level 4

Dose Level 5

Area Under the Curve of the Compound Dexanabinol (ETS2101) From Pre-dose up to 48 Hours Post Dose

Pharmacodynamic Biomarker Assessment

Single oral dose of dexanabinol at Dose Level 1

Dexanabinol: Oral formulation of dexanabinol

Single oral dose of dexanabinol at Dose level 2

Dexanabinol: Oral formulation of dexanabinol

Single oral dose of dexanabinol at Dose level 3

Dexanabinol: Oral formulation of dexanabinol

Single oral dose of dexanabinol at Dose level 4

Dexanabinol: Oral formulation of dexanabinol

Single oral dose of dexanabinol at Dose level 5

Dexanabinol: Oral formulation of dexanabinol

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Assessment of Single Doses of Oral Dexanabinol in Healthy Subjects	NCT02054754	Safety Tolerability Pharmacokinetic... Cancer	Dexanabinol Dos... Dexanabinol Dos... Dexanabinol Dos... Dexanabinol Dos... Dexanabinol Dos... Placebo	18 Years - 45 Years	e-Therapeutics PLC
Assessment of Single Doses of Oral Dexanabinol in Healthy Subjects	NCT02054754	Safety Tolerability Pharmacokinetic... Cancer	Dexanabinol Dos... Dexanabinol Dos... Dexanabinol Dos... Dexanabinol Dos... Dexanabinol Dos... Placebo	18 Years - 45 Years	e-Therapeutics PLC

Spots Global Cancer Trial Database for dexanabinol dose level 5