Phase 1
Completed N=40
Assessment of Single Doses of Oral Dexanabinol in Healthy Subjects
Safety · Tolerability · Pharmacokinetics · Cancer
Source: ClinicalTrials.gov NCT02054754 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2016
Primary outcomePrimary: Safety and Tolerability Based on the Number of Participants With Adverse Events and Comparison of Baseline and Post Dose Parameters — 9; 1 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability Based on the Number of Participants With Adverse Events and Comparison of Baseline and Post Dose Parameters |
9; 1 | — |
| SECONDARY Area Under the Curve of the Compound Dexanabinol (ETS2101) From Pre-dose up to 48 Hours Post Dose |
37.5; 61.3; 109; 226; 192 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02054754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.