Trial Outcomes & Findings for Assessment of Single Doses of Oral Dexanabinol in Healthy Subjects (NCT NCT02054754)

NCT ID: NCT02054754

Last Updated: 2016-05-23

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

40 participants

Primary outcome timeframe

Participants will be followed until follow up visit, 6-11 days after dosing

Results posted on

2016-05-23

Participant Flow

Participant milestones

Participant milestones
Measure	Dexanabinol Dose Level 1 Single oral dose of dexanabinol at Dose Level 1 Dexanabinol: Oral formulation of dexanabinol	Dexanabinol Dose Level 2 Single oral dose of dexanabinol at Dose level 2 Dexanabinol: Oral formulation of dexanabinol	Dexanabinol Dose Level 3 Single oral dose of dexanabinol at Dose level 3 Dexanabinol: Oral formulation of dexanabinol	Dexanabinol Dose Level 4 Single oral dose of dexanabinol at Dose level 4 Dexanabinol: Oral formulation of dexanabinol	Dexanabinol Dose Level 5 Single oral dose of dexanabinol at Dose level 5 Dexanabinol: Oral formulation of dexanabinol	Placebo Single oral dose of matching placebo Placebo
Overall Study STARTED	6	6	6	6	6	10
Overall Study COMPLETED	6	6	6	6	6	10
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of Single Doses of Oral Dexanabinol in Healthy Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexanabinol n=30 Participants Single oral dose of dexanabinol Dexanabinol: Oral formulation of dexanabinol	Placebo n=10 Participants Single oral dose of matching placebo Placebo	Total n=40 Participants Total of all reporting groups
Age, Continuous	32.8 years STANDARD_DEVIATION 8.5 • n=99 Participants	28.1 years STANDARD_DEVIATION 8.3 • n=107 Participants	31.1 years STANDARD_DEVIATION 8.5 • n=206 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Male	30 Participants n=99 Participants	10 Participants n=107 Participants	40 Participants n=206 Participants

PRIMARY outcome

Timeframe: Participants will be followed until follow up visit, 6-11 days after dosing

Outcome measures

Outcome measures
Measure	Dexanabinol n=30 Participants Single oral dose of dexanabinol Dexanabinol: Oral formulation of dexanabinol	Placebo n=10 Participants Single oral dose of matching placebo Placebo	Dose Level 3	Dose Level 4	Dose Level 5
Safety and Tolerability Based on the Number of Participants With Adverse Events and Comparison of Baseline and Post Dose Parameters	9 participants	1 participants	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Dexanabinol n=1 Participants Single oral dose of dexanabinol Dexanabinol: Oral formulation of dexanabinol	Placebo n=6 Participants Single oral dose of matching placebo Placebo	Dose Level 3 n=6 Participants	Dose Level 4 n=6 Participants	Dose Level 5 n=6 Participants
Area Under the Curve of the Compound Dexanabinol (ETS2101) From Pre-dose up to 48 Hours Post Dose	37.5 ng.h/mL Standard Deviation 0	61.3 ng.h/mL Standard Deviation 75.7	109 ng.h/mL Standard Deviation 102.7	226 ng.h/mL Standard Deviation 50.7	192 ng.h/mL Standard Deviation 68.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.