Assessment of Single Doses of Oral Dexanabinol in Healthy Subjects

Phase 1

Completed

• Conditions: Tolerability; Safety; Cancer; Pharmacokinetics
• Interventions: Drug: Dexanabinol Dose Level 2; Drug: Dexanabinol Dose Level 4; Drug: Dexanabinol Dose Level 5; Drug: Dexanabinol Dose Level 1; Drug: Placebo; Drug: Dexanabinol Dose Level 3

• Registration Number: NCT02054754
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-20
• Study Start: 2014-01
• Study First Submitted QC: 2014-02-03
• Study First Posted: 2014-02-04
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Results First Submitted: 2016-01-25
• Status Verified: 2016-05
• Results First Submitted QC: 2016-05-17
• Last Update Submitted: 2016-05-17
• Results First Posted: 2016-05-23
• Last Update Posted: 2016-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexanabinol Dose Level 2	Dexanabinol Dose Level 2	Single oral dose of dexanabinol
Dexanabinol Dose Level 4	Dexanabinol Dose Level 4	Single oral dose of dexanabinol
Dexanabinol Dose Level 5	Dexanabinol Dose Level 5	Single oral dose of dexanabinol
Dexanabinol Dose Level 1	Dexanabinol Dose Level 1	Single oral dose of dexanabinol
Placebo	Placebo	Single oral dose of matching placebo
Dexanabinol Dose Level 3	Dexanabinol Dose Level 3	Single oral dose of dexanabinol

Primary Outcome Measures

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

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

Trial Locations

Locations (1)

Quotient Clinical; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom