NCT04930796

Food Effect Study of VER-01 in Healthy Volunteers

Randomized Open-label Study to Evaluate the Pharmacokinetics and Safety of VER-01 After Single Dose With and Without Meal in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Vertanical GmbH · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Evaluation of pharmacokinetics, tolerability and safety of VER-01 depending on the intake a high-fat meal in healthy volunteers

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	VER-01	standardised cannabis extract (containing 21 mg THC per gram drug product)

Timeline

• Start date: 2022-08-10
• Primary completion: 2022-11-17
• Completion: 2022-11-24
• First posted: 2021-06-18
• Last updated: 2022-11-28

Locations

1 site across 1 country: Austria