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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

Completed

Started Jan 2014

Shorter than P25 for phase_1

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8 months study duration

First Submitted

Initial submission to the registry

November 20, 2013

Completed

1 month until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed

1 month until next milestone

First Posted

Study publicly available on registry

February 4, 2014

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed

1.7 years until next milestone

Results Posted

Study results publicly available

May 23, 2016

Completed

Last Updated

May 23, 2016

Status Verified

May 1, 2016

Enrollment Period

8 months

First QC Date

November 20, 2013

Results QC Date

January 25, 2016

Last Update Submit

May 17, 2016

Conditions

Safety Tolerability Pharmacokinetics Cancer

Keywords

DexanabinolOralSafetyTolerabilityPharmacokinetics

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Other Outcomes (1)

Pharmacodynamic Biomarker Assessment
Pre-dose, 1, 6 and 24 hours post dose