Assessment of Single Doses of Oral Dexanabinol in Healthy Subjects

• Sponsor: e-Therapeutics PLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02054754
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 6
• Duration (Months): 8
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Safety; Tolerability; Pharmacokinetics; Cancer	Drug: Dexanabinol Dose Level 1; Drug: Dexanabinol Dose Level 2; Drug: Dexanabinol Dose Level 3; Drug: Dexanabinol Dose Level 4; Drug: Dexanabinol Dose Level 5; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Assessment of Safety, Tolerability and Pharmacokinetics of Single Doses of Oral Dexanabinol in Healthy Subjects
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexanabinol Dose Level 1 Single oral dose of dexanabinol	Drug: Dexanabinol Dose Level 1; Oral formulation of dexanabinol; Other Names: ETS2101
Experimental: Dexanabinol Dose Level 2 Single oral dose of dexanabinol	Drug: Dexanabinol Dose Level 2; Oral formulation of dexanabinol; Other Names: ETS2101
Experimental: Dexanabinol Dose Level 3 Single oral dose of dexanabinol	Drug: Dexanabinol Dose Level 3; Oral formulation of dexanabinol; Other Names: ETS2101
Experimental: Dexanabinol Dose Level 4 Single oral dose of dexanabinol	Drug: Dexanabinol Dose Level 4; Oral formulation of dexanabinol; Other Names: ETS2101
Experimental: Dexanabinol Dose Level 5 Single oral dose of dexanabinol	Drug: Dexanabinol Dose Level 5; Oral formulation of dexanabinol; Other Names: ETS2101
Placebo Comparator: Placebo Single oral dose of matching placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. 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

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]

   Pharmacokinetic parameters will be assessed in a blinded fashion at the end of each cohort, prior to dose escalation.

Other Outcome Measures

1. Pharmacodynamic Biomarker Assessment [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Quotient Clinical	Nottingham	Nottinghamshire	United Kingdom	NG11 6JS

Sponsors and Collaborators

• e-Therapeutics PLC

Investigators

• Principal Investigator: Philip Evans, MD, Quotient Clinical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: e-Therapeutics PLC
• ClinicalTrials.gov Identifier: NCT02054754
• Other Study ID Numbers: ETS2101-101
• First Posted: Feb 4, 2014
• Last Update Posted: May 23, 2016
• Last Verified: May 1, 2016

• Keywords provided by e-Therapeutics PLC: Dexanabinol; Oral; Safety; Tolerability; Pharmacokinetics
• Additional relevant MeSH terms: HU 211; Dronabinol

Study Results

Participant Flow

Arm/Group Title	Dexanabinol Dose Level 1	Dexanabinol Dose Level 2	Dexanabinol Dose Level 3	Dexanabinol Dose Level 4	Dexanabinol Dose Level 5	Placebo
Arm/Group Description	Single oral dose of dexanabinol at Dose Level 1 Dexanabinol: Oral formulation of dexanabinol	Single oral dose of dexanabinol at Dose level 2 Dexanabinol: Oral formulation of dexanabinol	Single oral dose of dexanabinol at Dose level 3 Dexanabinol: Oral formulation of dexanabinol	Single oral dose of dexanabinol at Dose level 4 Dexanabinol: Oral formulation of dexanabinol	Single oral dose of dexanabinol at Dose level 5 Dexanabinol: Oral formulation of dexanabinol	Single oral dose of matching placebo Placebo
Period Title: Overall Study
STARTED	6	6	6	6	6	10
COMPLETED	6	6	6	6	6	10
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Dexanabinol	Placebo	Total
Arm/Group Description	Single oral dose of dexanabinol Dexanabinol: Oral formulation of dexanabinol	Single oral dose of matching placebo Placebo	Total of all reporting groups
Overall Participants	30	10	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.8 (8.5)	28.1 (8.3)	31.1 (8.5)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	30 100%	10 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	Safety and Tolerability Based on the Number of Participants With Adverse Events and Comparison of Baseline and Post Dose Parameters
Description	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
Time Frame	Participants will be followed until follow up visit, 6-11 days after dosing

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexanabinol	Placebo
Arm/Group Description	Single oral dose of dexanabinol Dexanabinol: Oral formulation of dexanabinol	Single oral dose of matching placebo Placebo
Measure Participants	30	10
Number [participants]	9 30%	1 10%

2. Secondary Outcome

Title	Area Under the Curve of the Compound Dexanabinol (ETS2101) From Pre-dose up to 48 Hours Post Dose
Description	Pharmacokinetic parameters will be assessed in a blinded fashion at the end of each cohort, prior to dose escalation.
Time Frame	Pre-dose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16,24,36,48 hours post dose

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexanabinol Dose Level 1	Dose Level 2	Dose Level 3	Dose Level 4	Dose Level 5
Arm/Group Description
Measure Participants	1	6	6	6	6
Mean (Standard Deviation) [ng.h/mL]	37.5 (0)	61.3 (75.7)	109 (102.7)	226 (50.7)	192 (68.6)

3. Other Pre-specified Outcome

Title	Pharmacodynamic Biomarker Assessment
Description	Blood samples taken and analysed for the purposes of the identification and quantification of pharmacodynamic biomarkers pre-dose and at several points after dosing.
Time Frame	Pre-dose, 1, 6 and 24 hours post dose

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Dexanabinol Dose Level 1		Dexanabinol Dose Level 2		Dexanabinol Dose Level 3		Dexanabinol Dose Level 4		Dexanabinol Dose Level 5		Placebo
Arm/Group Description	Single oral dose of dexanabinol Dexanabinol: Oral formulation of dexanabinol		Single oral dose of dexanabinol Dexanabinol: Oral formulation of dexanabinol		Single oral dose of dexanabinol Dexanabinol: Oral formuulation of dexanabinol		Single oral dose of dexanabinol Dexanabinol: Oral formulation of dexanabinol		Single oral dose of dexanabinol Dexanabinol: Oral formulation of dexanabinol		Single oral dose of matching placebo Placebo
All Cause Mortality
	Dexanabinol Dose Level 1		Dexanabinol Dose Level 2		Dexanabinol Dose Level 3		Dexanabinol Dose Level 4		Dexanabinol Dose Level 5		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Dexanabinol Dose Level 1		Dexanabinol Dose Level 2		Dexanabinol Dose Level 3		Dexanabinol Dose Level 4		Dexanabinol Dose Level 5		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Dexanabinol Dose Level 1		Dexanabinol Dose Level 2		Dexanabinol Dose Level 3		Dexanabinol Dose Level 4		Dexanabinol Dose Level 5		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/6 (50%)		1/6 (16.7%)		1/6 (16.7%)		3/6 (50%)		1/6 (16.7%)		1/10 (10%)
Gastrointestinal disorders
Diarrhoea	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	2/6 (33.3%)	2	0/6 (0%)	0	1/10 (10%)	1
Abdominal pain	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/10 (0%)	0
Infections and infestations
Lower respiratory tract infection	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/10 (0%)	0
Acute otitis media	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/10 (0%)	0
Pyelonephritis	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/10 (0%)	0
Rhinitis	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/10 (0%)	0
Upper respiratory tract infection	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/10 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/10 (0%)	0
Musculo-skeletal stiffness	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/10 (0%)	0
Myalgia	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/10 (0%)	0
Nervous system disorders
Headache	1/6 (16.7%)	1	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/10 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.