A randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single oral doses of CB1 antagonist ANEB-001 in healthy occasional cannabis users

Signed informed consent prior to any study-mandated procedure

Healthy male or female subjects, 18 to 45 years of age, inclusive at screening.

Body mass index (BMI) between 18 and 30 kg/m2, inclusive at screening, and with a minimum weight of 50 kg.

All women of child bearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 90 days after their last dose of study treatment.

Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.

Occasional cannabis users with

a. Lifetime cannabis use on at least 10 occasions.

b. In the past 6 months, the mean cannabis use should not exceed one occasion per week.

c. Subjects should be able to refrain from using cannabinoids at least 3 weeks prior to dosing up to the end of the study.

d. Urine drug screen must be negative prior to dosing.

Are the trial subjects under 18? no

Number of subjects for this age range:

F.1.2 Adults (18-64 years) yes

F.1.2.1 Number of subjects for this age range 180

F.1.3 Elderly (>=65 years) no

F.1.3.1 Number of subjects for this age range

Participation in an investigational drug or device study (last dosing of previous study was within 90 days prior to first dosing of this study).

History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 21 units alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquillisers, or any other addictive agent other than recreative use of THC

Positive test for drugs of abuse (other than THC) at screening.

Positive test for drugs of abuse pre-dose.

If a woman:, pregnant, or breast-feeding, or planning to become pregnant during the study.

Clinically significant suicidal ideation in the past 5 years as judged by the investigator or any life-time suicide attempts.

History of cannabis-induced psychosis, schizophrenia or other clinically relevant psychiatric disorders, as judged by the investigator.

History of a clinically significant mood disorder, including but not limited to major depressive disorder, as judged by the investigator.