THC intoxication
Conditions
Interventions
Product Name: ANEB001
Product Code: ANEB001
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: ANEB-001
Current Sponsor code: ANEB-001
Other descriptive name: V24343
Concentration unit: mg millig
Sponsors
Anebulo pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent prior to any study-mandated procedure 2. Healthy male or female subjects, 18 to 45 years of age, inclusive at screening. 3. Body mass index (BMI) between 18 and 30 kg/m2, inclusive at screening, and with a minimum weight of 50 kg. 4. 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. 5. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions. 6. 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
Exclusion criteria
Exclusion criteria: 8. Participation in an investigational drug or device study (last dosing of previous study was within 90 days prior to first dosing of this study). 9. 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 10. Positive test for drugs of abuse (other than THC) at screening. 11. Positive test for drugs of abuse pre-dose. 17. If a woman:, pregnant, or breast-feeding, or planning to become pregnant during the study. 19. Clinically significant suicidal ideation in the past 5 years as judged by the investigator or any life-time suicide attempts. 20. History of cannabis-induced psychosis, schizophrenia or other clinically relevant psychiatric disorders, as judged by the investigator. 21. History of a clinically significant mood disorder, including but not limited to major depressive disorder, as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To investigate the inhibition of primary CNS effects of a THC challenge by CB1 receptor antagonist compared to placebo in healthy occasional users of cannabis;Secondary Objective: • To investigate the inhibition of secondary CNS effects of a THC challenge by CB1 receptor antagonist compared to placebo in healthy occasional users of cannabis • To evaluate the pharmacokinetics of ANEB-001, THC, 11-OH-THC and 11-nor-9 carboxy-THC in plasma • To evaluate the pharmacokinetics of ANEB-001 and potential metabolites in urine (Part B cohort 3 to 6 and Part C only) • To assess safety and tolerability of ANEB-001 in healthy occasional users of cannabis Part C only: •To evaluate the CNS effects of a high-dose THC challenge administered simultaneously with the CB1 receptor antagonist ANEB-001 relative to baseline in healthy occasional users of cannabis.;Primary end point(s): • Visual Analogue Scale (VAS) “Feeling High” according to modified Bowdle psychedelic scale (mm) • VAS “Alertness” according to Bond and Lader (mm) • Body sway: o antero-posterior sway (mm); • Heart rate (bpm). ;Timepoint(s) of evaluation of this end point: for VAS and Body sway ; pre dose till 8 hrs post dose (hourly) HR ; day -1 - FU (7-14 days after dosing) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): CNS effects • VAS Bond and Lader: o mood (mm), o calmness (mm). • VAS Bowdle o Internal perception o External perception •State-Trait Anxiety Inventory (STAI) o State anxiety score • Saccadic eye movements: o saccadic reaction time (second), o saccadic peak velocity (degrees/second), and o saccadic inaccuracy (%); • Smooth pursuit eye movements: o percentage of time the eyes of the subjects are in smooth pursuit of the target (%); • Adaptive tracking: o average performance (%); • Pupillometry (mm) • N-Back o Average reaction time for zero, one and two-back (ms) o (nr correct – nr incorrect)/total for zero, one and two-back Starting with cohort 3 of Part B: • VAS “Any drug effect” (mm) • VAS “Good drug effect” (mm) • VAS “Bad drug effect” (mm) PD outcomes starting in Part C: State-Trait Anxiety Inventory, VAS ”Mood”, VAS “Calmness” (Bond&Lader), VAS “Internal perception”, VAS “External Perception” (Bowdle), VAS “Any drug effect”, VAS “Good drug effect” and VAS “Bad drug effect”, Symbol Digit Substitution Test (SDST), Visual Verbal Learning Test (VVLT), Alternate finger tapping (AFT), Timed Up and Go (TUG), Basic Symptom Inventory (BSI), Brief Psychiatric Rating Scale (BPRS), Clinical Global Impression of Severity (CGIS), exploratory accelerometer-based measurements PK PK parameters of ANEB-001, THC and 11-OH-THC by non-compartmental analysis of the plasma concentration-time data: • AUCinf, AUClast, CL/F, Cmax, t1/2, tlag, tmax, Vz/F • Dose-normalized PK parameters: AUCinf, AUClast, Cmax • Urine PK parameters: Aelast, Aelast%, CLR Safety and tolerability • Treatment-emergent (serious) adverse events ((S)AEs) throughout the study at every study visit • Concomitant medication throughout the study at every study visit • Vital signs (Pulse Rate (bpm), Systolic blood pressure (mmHg), Diastolic blood pressure (mmHg)), Respiratory Rate (pm), O2 Saturation (%)) as per assessment schedule • Clinical laboratory tests (Hematology, blood chemi | — |
Countries
Netherlands
Outcome results
None listed