Assessment of Single Doses of Oral Dexanabinol in Healthy Subjects

May 17, 2016 updated by: e-Therapeutics PLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG11 6JS
        • Quotient Clinical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexanabinol Dose Level 1
Single oral dose of dexanabinol
Drug: Dexanabinol Dose Level 1
Oral formulation of dexanabinol
Other Names:
  • ETS2101
Experimental: Dexanabinol Dose Level 2
Single oral dose of dexanabinol
Drug: Dexanabinol Dose Level 2
Oral formulation of dexanabinol
Other Names:
  • ETS2101
Experimental: Dexanabinol Dose Level 3
Single oral dose of dexanabinol
Drug: Dexanabinol Dose Level 3
Oral formulation of dexanabinol
Other Names:
  • ETS2101
Experimental: Dexanabinol Dose Level 4
Single oral dose of dexanabinol
Drug: Dexanabinol Dose Level 4
Oral formulation of dexanabinol
Other Names:
  • ETS2101
Experimental: Dexanabinol Dose Level 5
Single oral dose of dexanabinol
Drug: Dexanabinol Dose Level 5
Oral formulation of dexanabinol
Other Names:
  • ETS2101
Placebo Comparator: Placebo
Single oral dose of matching placebo
Drug: Placebo

What is the study measuring?

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
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
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
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.
Pre-dose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16,24,36,48 hours post dose

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-dose, 1, 6 and 24 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

e-Therapeutics PLC

Investigators

  • Principal Investigator: Philip Evans, MD, Quotient Clinical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

November 20, 2013

First Submitted That Met QC Criteria

February 3, 2014

First Posted (Estimate)

February 4, 2014

Study Record Updates

Last Update Posted (Estimate)

May 23, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETS2101-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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