Does a lipid formulation increase the absorption of cannabidiol?

Phase 1

Completed

• Conditions: Pharmacokinetics of a novel CBD formulation in healthy participants; Not Applicable

• Registration Number: ISRCTN18067579
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-30
• Study Completion: 2022-09-01
• Last Update Posted: 16 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Current inclusion criteria as of 13/04/2022:
1. Healthy volunteers. Defined as healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine.
2. Aged 18-45 years
3. Agree to fast 15 hours, i.e. 10 pm to 1 pm on dosing days
4. Capable of giving informed consent
5. Written informed consent from participant

_____

Previous inclusion criteria:
1. Healthy volunteers
2. Age 18-45 years
3. Females of childbearing potential and males must be willing to use highly effective method of contraception (hormonal or barrier method of birth control; abstinence) throughout the duration of the study and for at least 4 weeks after
4. Agreeing to fast 15 hours; 10pm-1pm on dosing days
5. Capable of giving informed consent
6. Written informed consent from participant

Exclusion Criteria

Current exclusion criteria as of 13/04/2022:
1. Clinically relevant medical history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the participant
2. Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer’s participation in the trial or make it unnecessarily hazardous
3. Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, or history of any neurological or mental illness
4. Surgery or medical condition that might affect absorption of medicines
5. Blood pressure and heart rate in supine position at the screening examination outside the following ranges. Repeat measurements are permitted if values are borderline (i.e. values that are within 5 mm Hg for blood pressure or 5 beats/min for heart rate) or if requested by the investigator. Subjects can be included if the repeat value is within range or still borderline but deemed not clinically significant by the investigator.
5.1. Blood pressure 90–140 mm Hg systolic, 40–90 mm Hg diastolic
5.2. Heart rate 40–100 beats/min
6. Loss of more than 400 ml blood during the 3 months before the trial, e.g. as a blood donor
7. Any prescribed medication (apart from contraceptives)
8. Use of any CBD products within 6 months of IMP administration
9. Use of any over-the-counter medications or health supplements within the past 2 weeks
10. BMI <18 or >30 kg/m2
11. History of alcohol or substance misuse disorder
12. Intake of more than 14 units of alcohol weekly.
13. Smokes more than 10 cigarettes per day
14. Use of any illicit substances within the last 6 months
15. Pregnant or breastfeeding
16. Women of childbearing potential (as defined in CTFG guidelines, see 5.7 Concomitant Medication) not willing to use a highly effective form of contraception (as defined in CTFG guidelines, see section 5.7 Concomitant Medication) during participation in the study or male patients not willing to ensure use of a condom during participation in the study
17. eGFR =70 ml/min
18. Any liver function or renal function test abnormality. A repeat is allowed on one occasion for determination of eligibility.
19. Urine drug screen positive for any substances
20. Positive alcohol breath test
21. Participant in any other clinical trial or experimental drug study in the past 3 months
22. Known hypersensitivity to CBD and/or SEEK formulation excipients
23. Not able to swallow capsules
_____

Previous exclusion criteria:
1. Any prescribed medication (apart from contraceptives)
2. Use of any CBD products within six months of IMP administration
3. Use of any over-the-counter medications or health supplements within the past 2 weeks
4. BMI <18 or >30.0 kg/m²
5. History of alcohol or substance misuse disorder
6. Smokes more than 10 cigarettes per day
7. Use of any illicit subs

Study & Design

• Study Type: Interventional
• Study Design: Not specified