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Assessment of Single Doses of Oral Dexanabinol in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02054754
Recruitment Status : Completed
First Posted : February 4, 2014
Results First Posted : May 23, 2016
Last Update Posted : May 23, 2016
Sponsor:
Information provided by (Responsible Party):
e-Therapeutics PLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Safety Tolerability Pharmacokinetics Cancer 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 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Assessment of Safety, Tolerability and Pharmacokinetics of Single Doses of Oral Dexanabinol in Healthy Subjects
Study Start Date : January 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
Experimental: Dexanabinol Dose Level 1
Single oral dose of dexanabinol
Drug: Dexanabinol Dose Level 1
Oral formulation of dexanabinol
Other Name: ETS2101

Experimental: Dexanabinol Dose Level 2
Single oral dose of dexanabinol
Drug: Dexanabinol Dose Level 2
Oral formulation of dexanabinol
Other Name: ETS2101

Experimental: Dexanabinol Dose Level 3
Single oral dose of dexanabinol
Drug: Dexanabinol Dose Level 3
Oral formulation of dexanabinol
Other Name: ETS2101

Experimental: Dexanabinol Dose Level 4
Single oral dose of dexanabinol
Drug: Dexanabinol Dose Level 4
Oral formulation of dexanabinol
Other Name: ETS2101

Experimental: Dexanabinol Dose Level 5
Single oral dose of dexanabinol
Drug: Dexanabinol Dose Level 5
Oral formulation of dexanabinol
Other Name: ETS2101

Placebo Comparator: Placebo
Single oral dose of matching placebo
Drug: Placebo



Primary Outcome Measures :
  1. Safety and Tolerability Based on the Number of Participants With Adverse Events and Comparison of Baseline and Post Dose Parameters [ Time Frame: Participants will be followed until follow up visit, 6-11 days 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


Secondary Outcome Measures :
  1. Area Under the Curve of the Compound Dexanabinol (ETS2101) From Pre-dose up to 48 Hours Post Dose [ Time Frame: Pre-dose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16,24,36,48 hours post dose ]
    Pharmacokinetic parameters will be assessed in a blinded fashion at the end of each cohort, prior to dose escalation.


Other Outcome Measures:
  1. Pharmacodynamic Biomarker Assessment [ Time Frame: Pre-dose, 1, 6 and 24 hours post dose ]
    Blood samples taken and analysed for the purposes of the identification and quantification of pharmacodynamic biomarkers pre-dose and at several points after dosing.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054754


Locations
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United Kingdom
Quotient Clinical
Nottingham, Nottinghamshire, United Kingdom, NG11 6JS
Sponsors and Collaborators
e-Therapeutics PLC
Investigators
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Principal Investigator: Philip Evans, MD Quotient Clinical
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Responsible Party: e-Therapeutics PLC
ClinicalTrials.gov Identifier: NCT02054754    
Other Study ID Numbers: ETS2101-101
First Posted: February 4, 2014    Key Record Dates
Results First Posted: May 23, 2016
Last Update Posted: May 23, 2016
Last Verified: May 2016
Keywords provided by e-Therapeutics PLC:
Dexanabinol
Oral
Safety
Tolerability
Pharmacokinetics
Additional relevant MeSH terms:
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HU 211
Dronabinol
Anti-Arrhythmia Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Hallucinogens
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists