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Completed

NCT Number: NCT02054754

Assessment 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.

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Key information

Conditions

Safety Cancer Neoplasms Pharmacokinetics Tolerability

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Clinical

Nottingham, Nottinghamshire, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexanabinol Dose Level 1

Drug

Oral formulation of dexanabinol

Other names: ETS2101

Dexanabinol Dose Level 2

Drug

Oral formulation of dexanabinol

Other names: ETS2101

Dexanabinol Dose Level 3

Drug

Oral formulation of dexanabinol

Other names: ETS2101

Dexanabinol Dose Level 4

Drug

Oral formulation of dexanabinol

Other names: ETS2101

Dexanabinol Dose Level 5

Drug

Oral formulation of dexanabinol

Other names: ETS2101

Placebo

Drug

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

e-Therapeutics PLC

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 4, 2014
Registry last updated
May 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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