Assessment of Single Doses of Oral Dexanabinol in Healthy Subjects

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02054754
• Other study ID #: ETS2101-101
• Status: Completed
• Phase: Phase 1
• First received: November 20, 2013
• Last updated: October 9, 2014
• Start date: January 2014
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: e-Therapeutics PLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cancer
• Pharmacokinetics
• Safety
• Tolerability

Intervention

Drug:
• Dexanabinol
Oral formulation of dexanabinol
• Placebo

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
e-Therapeutics PLC

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pharmacodynamic biomarker assessment	Blood samples taken and analysed for the purposes of the identification and quantification of pharmacodynamic biomarkers pre-dose and at several points after dosing.	Pre-dose, 1, 6 and 24 hours post dose	No
Primary	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	Participants will be followed until follow up visit, 6-11 days after dosing	Yes
Secondary	Pharmacokinetics: Area under curve (AUC)	Pharmacokinetic parameters will be assessed in a blinded fashion at the end of each cohort, prior to dose escalation.	Pre-dose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16,24,36,48 hours post dose	No