SafetyPhase 1NCT02054754

Assessment of Single Doses of Oral Dexanabinol in Healthy Subjects

A Phase 1 study testing Dexanabinol Dose Level 1, Dexanabinol Dose Level 2 and Dexanabinol Dose Level 3 in people with Safety and Tolerability, run by e-Therapeutics PLC at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Safety, Tolerability, Pharmacokinetics
What is being tested?: Dexanabinol Dose Level 1, Dexanabinol Dose Level 2 and Dexanabinol Dose Level 3
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteUnited Kingdom
Study dates: Jan 2014to Sep 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Quotient Clinical
Nottingham, Nottinghamshire, NG11 6JS

Other trials in United Kingdom

About this study

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

Conditions: Safety, Tolerability, Pharmacokinetics, Cancer
Being tested: Dexanabinol Dose Level 1, Dexanabinol Dose Level 2, Dexanabinol Dose Level 3, Dexanabinol Dose Level 4, Dexanabinol Dose Level 5
Keywords: Dexanabinol, Oral, Safety, Tolerability, Pharmacokinetics
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dexanabinol Dose Level 1Drug
Also called ETS2101
Oral formulation of dexanabinol
Dexanabinol Dose Level 2Drug
Also called ETS2101
Oral formulation of dexanabinol
Dexanabinol Dose Level 3Drug
Also called ETS2101
Oral formulation of dexanabinol
Dexanabinol Dose Level 4Drug
Also called ETS2101
Oral formulation of dexanabinol
Dexanabinol Dose Level 5Drug
Also called ETS2101
Oral formulation of dexanabinol
PlaceboDrug

Study groups in NCT02054754
Study group	Role	What they receive
Dexanabinol Dose Level 1	Experimental	Single oral dose of dexanabinol Receives: Drug: Dexanabinol Dose Level 1
Dexanabinol Dose Level 2	Experimental	Single oral dose of dexanabinol Receives: Drug: Dexanabinol Dose Level 2
Dexanabinol Dose Level 3	Experimental	Single oral dose of dexanabinol Receives: Drug: Dexanabinol Dose Level 3
Dexanabinol Dose Level 4	Experimental	Single oral dose of dexanabinol Receives: Drug: Dexanabinol Dose Level 4
Dexanabinol Dose Level 5	Experimental	Single oral dose of dexanabinol Receives: Drug: Dexanabinol Dose Level 5
Placebo	Placebo comparator	Single oral dose of matching placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Pharmacokinetic parameters will be assessed in a blinded fashion at the end of each cohort, prior to dose escalation.
Measured: Pre-dose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16,24,36,48 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Sep 2014

First posted4 Feb 2014 (estimated)
Study startJan 2014
Primary completionSep 2014
Study completionSep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SafetyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02054754
Sponsor's protocol ID: ETS2101-101
Status last verified: May 2016
First submitted: 20 Nov 2013
Last updated: 23 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Safety trials

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Safety, Tolerability and Pharmacokinetics of Single Doses of Oral Dexanabinol in Healthy Subjects
ClinicalTrials.gov ID: NCT02054754
Acronym / sponsor ID: ETS2101-101
Conditions: Safety, Tolerability, Pharmacokinetics, Cancer
Keywords: Dexanabinol, Oral, Safety, Tolerability, Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: e-Therapeutics PLCIndustry (pharma, biotech, devices)
Study start: Jan 2014
Primary completion: Sep 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 4 Feb 2014 (estimated)
Results: Posted 23 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Dexanabinol Dose Level 1	Experimental	Drug: Dexanabinol Dose Level 1Single oral dose of dexanabinol
Dexanabinol Dose Level 2	Experimental	Drug: Dexanabinol Dose Level 2Single oral dose of dexanabinol
Dexanabinol Dose Level 3	Experimental	Drug: Dexanabinol Dose Level 3Single oral dose of dexanabinol
Dexanabinol Dose Level 4	Experimental	Drug: Dexanabinol Dose Level 4Single oral dose of dexanabinol
Dexanabinol Dose Level 5	Experimental	Drug: Dexanabinol Dose Level 5Single oral dose of dexanabinol
Placebo	Placebo comparator	Drug: PlaceboSingle oral dose of matching placebo

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dexanabinol Dose Level 1Also: ETS2101Oral formulation of dexanabinol	Drug	Dexanabinol Dose Level 1
Dexanabinol Dose Level 2Also: ETS2101Oral formulation of dexanabinol	Drug	Dexanabinol Dose Level 2
Dexanabinol Dose Level 3Also: ETS2101Oral formulation of dexanabinol	Drug	Dexanabinol Dose Level 3
Dexanabinol Dose Level 4Also: ETS2101Oral formulation of dexanabinol	Drug	Dexanabinol Dose Level 4
Dexanabinol Dose Level 5Also: ETS2101Oral formulation of dexanabinol	Drug	Dexanabinol Dose Level 5
Placebo	Drug	Placebo

Primary outcome

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

1 secondary outcome

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

Results and safety

Results posted to the registry on 23 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dexanabinol Dose Level 1	6	6
Dexanabinol Dose Level 2	6	6
Dexanabinol Dose Level 3	6	6
Dexanabinol Dose Level 4	6	6
Dexanabinol Dose Level 5	6	6
Placebo	10	10

Primary outcome: 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. Number. Unit: participants

Measure	Dexanabinol n = 30	Placebo n = 10
Value	9	1

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dexanabinol Dose Level 1	0 of 6 (0%)	3 of 6 (50%)	Not reported
Dexanabinol Dose Level 2	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
Dexanabinol Dose Level 3	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
Dexanabinol Dose Level 4	0 of 6 (0%)	3 of 6 (50%)	Not reported
Dexanabinol Dose Level 5	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
Placebo	0 of 10 (0%)	1 of 10 (10%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Not yet recruitingPhase 2
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Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Philip Evans, MD principal investigator

Quotient Clinical

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dexanabinol Dose Level 1, Dexanabinol Dose Level 2 and Dexanabinol Dose Level 3 in people with Safety and Tolerability, run by e-Therapeutics PLC at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02054754.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2016.