Last reviewed · How we verify
NCT02054754
Assessment of Safety, Tolerability and Pharmacokinetics of Single Doses of Oral Dexanabinol in Healthy Subjects
Phase 1 trial testing Dexanabinol Dose Level 1 in Safety in 40 participants. Completed in 1 September 2014.
1 September 2014
Quick facts
| Lead sponsor | e-Therapeutics PLC |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | basic science |
| Enrollment | 40 |
| Start date | 1 January 2014 |
| Primary completion | 1 September 2014 |
| Estimated completion | 1 September 2014 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Dexanabinol Dose Level 1 — full drug profile →
- Dexanabinol Dose Level 2 — full drug profile →
- Dexanabinol Dose Level 3 — full drug profile →
- Dexanabinol Dose Level 4 — full drug profile →
- Dexanabinol Dose Level 5 — full drug profile →
- Placebo
Conditions studied
- Safety — all drugs for Safety →
- Tolerability — all drugs for Tolerability →
- Pharmacokinetics — all drugs for Pharmacokinetics →
- Cancer — all drugs for Cancer →
Sponsor
e-Therapeutics PLC — full company profile →
Who can join
Adults 18 to 45, male only, with Safety or Tolerability. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Sponsor's own description
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
The current state and future perspectives of cannabinoids in cancer biology.
Śledziński P, Zeyland J, Słomski R, Nowak A. · · 2018 · cited 100× · PMID 29473338 · DOI 10.1002/cam4.1312 -
Cannabinoids in the landscape of cancer.
Mangal N, Erridge S, Habib N, Sadanandam A, et al · · 2021 · cited 72× · PMID 34259916 · DOI 10.1007/s00432-021-03710-7 -
Rescuing mitochondria in traumatic brain injury and intracerebral hemorrhages - A potential therapeutic approach.
Ahluwalia M, Kumar M, Ahluwalia P, Rahimi S, et al · · 2021 · cited 35× · PMID 34560175 · DOI 10.1016/j.neuint.2021.105192 -
Cannabinoids in Breast Cancer: Differential Susceptibility According to Subtype.
Almeida CF, Teixeira N, Correia-da-Silva G, Amaral C. · · 2021 · cited 26× · PMID 35011388 · DOI 10.3390/molecules27010156
Verify or expand the search:
- PubMed search for NCT02054754
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Safety
Currently open trials in the same condition.
- NCT06818994 — Safety and Efficacy of Psilocybin-assisted Psychotherapy for Demoralization Syndrome in Patients Diagnosed With Advanced · Phase 1 · recruiting
- NCT07286656 — A Study of GensSci098 in Subjects With Graves' Disease · Phase 1 · recruiting
- NCT06760208 — A Study to Learn More About Prevenar 20 Once it is Out in the Korean Market · recruiting
- NCT07157215 — An International Survey on the Use of NIV Outside the ICU · recruiting
- NCT06976229 — Safety and Early Efficacy of iPSC-Derived Motor Neuron Progenitor Cells (XS228) in Subacute Spinal Cord Injury: A Phase · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02054754 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by e-Therapeutics PLC
- Last refreshed: 17 May 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02054754.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing