Evaluation of pharmacokinetics, tolerability and safety of VER-01 depending on the intake a high-fat meal in healthy volunteers
Determination of the effect of food intake on the pharmacokinetic (PK) profile of VER-01 in healthy volunteers. Group 1: 9 subjects receive VER-01 (corresponding to 10 mg THC) in the morning after a 10-hour fasting period on day 1, and 30 minutes after the intake of a standardised high-fat breakfast has been started on day 4. Group 2: 9 subjects receive VER-01 (corresponding to 10 mg THC) in the morning after 30 minutes after the intake of a standardised high-fat breakfast has been started on day 1 and after a 10-hour fasting period on day 4.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
standardised cannabis extract (containing 21 mg THC per gram drug product)
University of Medicine in Vienna - Department of Clinical Pharmacology
Vienna, Austria
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC] - AUC 0-t
Analysis of AUC 0-t (AUC from time 0 to 24 hours) of THC over a defined period of time in dependance of a high-fat meal.
Time frame: On Day 1 and Day 4
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC] - AUC 0-∞
Analysis of AUC 0-∞ (AUC from time 0 extrapolated to infinity) of THC over a defined period of time in dependance of a high-fat meal.
Time frame: On Day 1 and Day 4
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC] - C max
Analysis of C max (maximum plasma concentration) of THC over a defined period of time in dependance of a high-fat meal.
Time frame: On Day 1 and Day 4
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - AUC 0-t
Analysis of AUC 0-t (AUC from time 0 to 24 hours) of 11-OH-THC and THC-COOH over a defined period of time in dependance of a high-fat meal.
Time frame: On Day 1 and Day 4
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - AUC 0-∞
Analysis of AUC 0-∞ (AUC from time 0 extrapolated to infinity)of 11-OH-THC and THC-COOH over a defined period of time in dependance of a high-fat meal.
Time frame: On Day 1 and Day 4
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - C max
Analysis of C max (maximum plasma concentration) of 11-OH-THC and THC-COOH over a defined period of time in dependance of a high-fat meal.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: On Day 1 and Day 4
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - λ z
Analysis of λ z (terminal elimination constant) of THC, 11-OH-THC and THC-COOH over a defined period of time in dependance of a high-fat meal.
Time frame: On Day 1 and Day 4
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - t 1/2
Analysis of t 1/2 (elimination half-life) of THC, 11-OH-THC and THC-COOH over a defined period of time in dependance of a high-fat meal.
Time frame: On Day 1 and Day 4
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - T max
Analysis of T max (time to reach Cmax)of THC, 11-OH-THC and THC-COOH over a defined period of time in dependance of a high-fat meal.
Time frame: On Day 1 and Day 4
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - C L/F
Analysis of C L/F (plasma clearance) of THC, 11-OH-THC and THC-COOH over a defined period of time in dependance of a high-fat meal.
Time frame: On Day 1 and Day 4
Pharmacokinetic profile of Δ9-tetrahydrocannabinol [THC], 11-Hydroxy-Δ9-tetrahydrocannabinol [11-OH-THC] and 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol [THC-COOH] - V area/F
Analysis of V area/F (volume of distribution) of THC, 11-OH-THC and THC-COOH over a defined period of time in dependance of a high-fat meal.
Time frame: On Day 1 and Day 4