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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02054754
Other study ID # ETS2101-101
Secondary ID
Status Completed
Phase Phase 1
First received November 20, 2013
Last updated October 9, 2014
Start date January 2014
Est. completion date September 2014

Study information

Verified date October 2014
Source e-Therapeutics PLC
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
Dexanabinol
Oral formulation of dexanabinol
Placebo


Locations

Country Name City State
United Kingdom Quotient Clinical Nottingham Nottinghamshire

Sponsors (1)

Lead Sponsor Collaborator
e-Therapeutics PLC

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Pharmacodynamic biomarker assessment 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 No
Primary 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 Yes
Secondary Pharmacokinetics: Area under curve (AUC) 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 No
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