Healthy volunteers. Intended indication is Clinical High Risk for Psychosis (CHR-P). Mental and Behavioural Disorders
Conditions
Interventions
Fourteen participants will be enrolled into the study (to provide a minimum of 12 evaluable participants).
Participants will receive the following dose regimens in a randomised order across 3 treatme
• Regimen B: 900 mg NW300EMCBD administered orally as 3 x 300 mg capsules following a HFHC meal
• Regimen C: 25 mg/kg Epidyolex solution administered orally as 2 x 12.5 mg/kg doses separated by 12 hours, each following a HFHC meal.
There will be a minimum 25-day washout period between the dosin
D6 to D9).
Participants will be required to return to the clinical research site for the end of study visit (EOSV) 25 days after the final dosing visit (i.e., 25 days after D1 of the third treatment
3 x approximately 25-day treatment periods) and involve a total of 29 visits (including 5 x visits per inpatient period per treatment period).
Sponsors
Clerkenwell Health
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male or female volunteers. 2. Age range between 18 and 55 years old. 3. Weight at least 50kg and have a body mass index (BMI) between 19 and 30 kg/m2 at screening. 4. Willingness to comply with and complete all study procedures, including consuming the protocol specified HFHC meal in 30 minutes. 5. In good health, as determined by no clinically significant findings from medical history, 12-lead ECG and vital signs measurements, and clinical laboratory evaluations at screening and check-in, and from the physical examination at check-in, as assessed by the investigator or designee. 6. Abstinence from consuming St John’s wort, grapefruit (juice), alcohol or tobacco and nicotine products for at least 72 hours prior to dosing and throughout treatment period. 7. Abstinence from caffeine for the duration of the in-clinic confinement period, including all dosing days. Caffeinated beverages and products will not be available on site. 8. Capable and willing to comply with protocol requirements during the study. 9. Participant is willing and able to give informed consent for participation in the study.
Exclusion criteria
Exclusion criteria: 1. Participation in a research trial within 90 days prior to Day 1, or 5 elimination half-lives prior to Day 1 (whichever is longer), or throughout the study. 2. Use of cannabis products, including hemp, in any form (including medication, oils, edibles or drinks) during the last 28 days before screening. 3. History of hypersensitivity or allergy to CBD oil, sesame oil, hemp or any other cannabinoid products, or any of the items that could be included in the standardized meals/snacks. 4. Using any regular medication in the 28 days prior to screening and throughout the study (as required doses of paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs) are permitted). 5. Abnormal screening sample: clinically significant liver, renal or haematological abnormalities, including total Bilirubin, ALT or AST > the upper limit of normal (ULN). 6. Positive screening test indicating active infection with HIV, hepatitis B virus or hepatitis C virus. Participants with evidence of past HBV infection and complete recovery may be eligible, at the discretion of the Investigator, provided liver function tests are within normal limits and there is no evidence of active infection. 7. Positive urine drug sample, including THC, at screening and, baseline excluding THC at post-dose. 8. Positive alcohol breathalyser test at screening and throughout the study. 9. Any suicidal ideation or behaviour in the past 12 months as assessed by responses to Columbia Suicidal Severity Rating questionnaire at screening. 10. Any history of mental disorder including major depressive disorder, bipolar disorder, psychosis, and any current substance use disorder, including alcohol and tobacco use disorder. 11. Any self-reported, observed or assessed medical condition that might put the subject at risk according to the physician’s opinion. 12. Any significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data. 13. Participants with a sitting blood pressure at screening, after resting for 5 minutes, higher than 140/90 mmHg or lower than 90/50 mmHg. 14. Blood donation or loss (eg surgery) over 200 ml in 3 months prior to screening and throughout study (menstruation is acceptable). 15. Male participants not willing to use contraceptive methods throughout the study. 16. Female participants who are pregnant (positive B-hCG urine test), lactating or breastfeeding. 17. Female participants of childbearing potential* and not willing to use highly effective contraceptive methods** at screening or throughout the study. *Defined as females who have experienced menarche and are not surgically sterilised (eg hysterectomy, bilateral salpingectomy) or post-menopausal. **Highly effective methods of birth control are those with a failure rate <1% per year and include combined oestrogen and progesterone hormonal contraception, progestogen-only hormonal contraception, intrauterine devices (IUD), intrauterine hormone-releasing systems (IUS) and vasectomised partner. 18. Participants with planned surgical or medical treatment requiring hospitalisation during the study. 19. Employees or family members of the Sponsor. 20. Participant unable to communicate reliably with research team. 21. Participant is not able to swallow capsules. 22. Subject unable or unwilling to consume the protocol specified HFHC mea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CBD, 7-OH-CBD, and 7-COOH-CBD pharmacokinetics parameters: Cmax, Tmax, AUCt, AUCinf, t1/2; Cmax/D, AUCt/D, AUCinf/D (pre-dose and at 15, 30, 45, 60, 80, 100, 120, 150 min, 3, 4, 5, 6, 9, 12, 24, 48, 72, 96, 120, 144, 168, and 192 h post-dose for Regimen A and Regimen B; pre-dose and at 15, 30, 45, 60, 80, 100, 120, 150 min, 3, 4, 5, 6, 9, 12 h post-first dose and 15, 30, 45, 60, 80, 100, 120, 150 min, 3, 4, 6, 12, 24, 48, 72, 96, 120, 144, 168, and 192 h post-second dose for Regimen C). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. CBD, 7-OH-CBD, and 7-COOH-CBD pharmacokinetics parameters: CL/F, Vz/F, Kel (pre-dose and at 15, 30, 45, 60, 80, 100, 120, 150 min, 3, 4, 5, 6, 9, 12, 24, 48, 72, 96, 120, 144, 168, and 192 h post-dose for Regimen A and Regimen B; pre-dose and at 15, 30, 45, 60, 80, 100, 120, 150 min, 3, 4, 5, 6, 9, 12 h post-first dose and 15, 30, 45, 60, 80, 100, 120, 150 min, 3, 4, 6, 12, 24, 48, 72, 96, 120, 144, 168, and 192 h post-second dose for Regimen C). 2. All reported adverse events using MedDRA V27 or above codes (from D1 to D9 of each treatment period and at the EOSV). 3. Changes from pre-dose baseline in laboratory findings after administration of oral doses of NW300EMCBD and Epidyolex (pre-dose and at 4, 24, 72, and 192 h post-dose for Regimen A and Regimen B; pre-dose, 4 h post-first dose, and at 4, 12, 24, 72, and 192 h post-second dose for Regimen C; and at the EOSV). 4. Changes from pre-dose baseline in vital signs over 192 hrs post-administration of oral doses of NW300EMCBD and Epidyolex (pre-dose and at 1, 2, 4, 8, 24, 48, 72, 96, 120, 144, 168, and 192 h post-dose for Regimen A and Regimen B; pre-dose and at 1, 2, 4, and 8 h post-first dose and at 1, 2, 4, 12, 24, 48, 72, 96, 120, 144, 168, and 192 h post-second dose for Regimen C; and at the EOSV). 5. Change from pre-dose baseline in ECG parameters (pre-dose and at 4 h post-dose for Regimen A, Regimen B, and Regimen C; and at the EOSV). 6. Change in gastrointestinal symptoms (pre-dose and at 3 and 24 h post-dose for Regimen A and Regimen B; pre-dose, 3 h post-first dose, and 12 and 24 h post-second dose for Regimen C). 7. Change in Columbia-Suicide Severity Rating Scale (C-SSRS) score (at screening; pre-dose and at 3, 24, 96, and 192 h post-dose for Regimen A and Regimen B; pre-dose, 3 h post-first dose, and at 12, 24, 96, and 192 h post-second dose for Regimen C; and at the EOSV). 8. Change in VAMS subscales (mental sedation subscale, tranquilisation and calming effects subscale, physical sedation subscale | — |
Countries
England, United Kingdom
Contacts
Public ContactRebeca James
Outcome results
None listed