Not applicable, study on healthy participants Other
Conditions
Interventions
After signing the informed consent form, at least 40 healthy adult male or female participants underwent screening assessments during an outpatient visit between Day -14 and Day -2.
Eligible participa
Sponsors
Aspeya, Switzerland
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Male or female non-tobacco smokers or mild tobacco smokers (1-10 cigarettes or nicotine e-cigarette per day) that were willing to comply with the study restrictions related to smoking 2. Age =18 and =55 years of age 3. BMI = 18.5 and = 30.0 kg/m2 4. Occasional smokers of cannabis (i.e. individuals who smoked cannabis products maximum once a week in the past 3 months) willing to refrain from cannabis products for 2 weeks prior to Day 1 5. Healthy participants, defined as absence of clinically significant illness and surgery within 4 weeks prior to dosing; absence of clinically significant history of neurological, endocrine, cardiovascular, dermatological, hematological, immunological, psychiatric (e.g., history of major depression or C-SSRS score above Type 1 ideation), gastrointestinal, renal, hepatic, and metabolic disease (e.g., diabetes) as well as any other medical history event considered clinically significant in the opinion of the investigator; absence of clinically significant history of respiratory (e.g., significant history of acute or chronic bronchospastic) disease (including asthma and chronic obstructive pulmonary disease treated or not treated); absence of any history of diagnosis of any other pulmonary disease that in the judgment of the investigator was likely to be exacerbated by inhalation of CBD from the device. 6. Female participants of childbearing potential must have had a negative pregnancy test result before administration of the study product and must have agreed not to donate ova (or egg(s)) for at least 30 days after the last dose of study product administration 7. Female participants of non-childbearing potential had to have/be: a) At least 12 months of spontaneous amenorrhea; or b) post surgically sterile (documented bilateral oophorectomy with or without hysterectomy) for at least 3 months prior to dosing 8. Female participants of childbearing potential who were sexually active with a non-sterile male partner (sterile male partners were defined as men vasectomized for at least 3 months prior to dosing) must have used two of the acceptable contraceptive methods throughout the study and for 30 days after the last dose: 8.1. Simultaneous use of hormonal contraceptive (e.g., oral, patch, depot injection, implant, vaginal ring, intrauterine device) or non-hormonal intrauterine device used for at least 4 weeks prior to dosing (must agree to use the same contraceptive throughout the study) and condom for the male partner 8.2. Simultaneous use of diaphragm or cervical cap with spermicide and condom for the male partner, started at least 21 days prior to dosing 8.3. True abstinence (i.e., refraining from heterosexual intercourse when this was in line with the preferred and usual lifestyle of the participant). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), lactational amenorrhea, and withdrawal were not acceptable) 9. Male participants who were not vasectomized for at least 3 months prior to dosing, and who were sexually active with a female partner of childbearing potential had to be willing to use one of the acceptable contraceptive methods from the first dose and for 90 days after the last dose: 9.1. Simultaneous use of condom and hormonal contraceptive (e.g., oral, patch, depot injection, implant, vaginal ring, intrauterine device) or non-hormonal intrauterine device used for at least 4 weeks prior to sexual intercourse for the female partner 9.2. Simultaneous use of
Exclusion criteria
Exclusion criteria: 1. Any clinically significant abnormal finding at physical examination at screening that could interfere with the objectives of the study 2. Clinically significant abnormal laboratory test results which in the opinion of the investigator could prevent participation in the study, at screening 3. Positive serology test results for HBsAg, HCV antibody, or HIV antigen and antibody at screening 4. Positive pregnancy test (at screening or Day -1) or lactating female participant 5. Positive urine drug (including cannabis related substances) screen and alcohol saliva test at screening or Day -1 6. Participant with abnormal lung function defined by spirometry testing such as: FEV1 < 80% of predicted normal value OR FEV1/FVC ratio < 0.70 at screening OR with post-bronchodilator FEV1 = 12% increase from pre-bronchodilator values (Reversibility testing) 7. Clinically significant ECG abnormalities at screening 8. Clinically significant vital signs abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, resting diastolic blood pressure lower than 50 or over 90 mmHg, or resting heart rate less than 50 or over 100 bpm) at screening 9. History of cannabis use disorder (i.e. mental health condition in which there was a problematic pattern of cannabis use that causes distress or impairs life) within 1 year prior to screening or of hard products (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening 10. History of alcohol use disorder (defined as a problematic pattern of alcohol use leading to clinically significant life impairment or distress) within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeded 10 units for women or 15 units for men of alcohol per week (1 unit = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%) 11. Known allergic reaction to CBD, or other related products, or to any excipient in the formulation 12. Any of the following laboratory parameters above 1.5 x upper limit of normal (ULN) at screening or baseline (Day -1): aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin. Analyses could be repeated once for confirmation. 13. History of liver disease or hepatic dysfunction (including cirrhosis), hyperbilirubinemia, jaundice, or elevated liver enzymes 14. History of epilepsy, major depression, schizophrenia or any other psychotic disorders 15. Use of medications for the timeframes specified below, except for medications exempted by the investigator on a case-by-case basis because they were judged unlikely to affect the PK profile of the study product or participant’s safety (e.g., topical drug products without significant systemic absorption): 15.1. current use of clobazam or valproate sodium, or use within 4 weeks prior to dosing; no other prescription medication from 14 days and over the counter (OTC) products from 7 days prior to dosing and throughout the study 15.2. Depot injection or implant within 3 months prior to dosing (excluding depot injection for contraception) 15.3. Any product known to induce or inhibit CYP3A4, CYP2C9 or CYP2C19 mediated hepatic drug metabolism, including St. John’s wort and cytochrome p450 (CYP) substrates of CYP1A2 (e.g., theophylline) and CYP2B6 (e.g., bupropion, efavirenz), CYP2C8 (e.g., montelukast), CYP2C9 (e.g. phenytoin), CYP2C19 (e.g., diazepam) and uridine 5' diphospho-glucuronosyltransfer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentrations of CBD measured using fully validated LC-MS/MS methods at Day 1 from pre-dose up to 72 h after the start of standardized dosing and Day 4 from pre-dose up to 6 h after the start of non-standardized dosing | — |
Countries
Switzerland
Contacts
Public ContactMilko Radicioni
Outcome results
None listed