Assessment of Single Doses of Oral Dexanabinol in Healthy Subjects

e-Therapeutics

Status and phase

Completed

Phase 1

Conditions

Cancer

Tolerability

Pharmacokinetics

Safety

Treatments

Drug: Dexanabinol Dose Level 5

Drug: Dexanabinol Dose Level 2

Drug: Dexanabinol Dose Level 3

Drug: Dexanabinol Dose Level 4

Drug: Dexanabinol Dose Level 1

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02054754

ETS2101-101

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 6 patient groups, including a placebo group

Dexanabinol Dose Level 1

Experimental group

Description: