NCT04930809

Single and Multiple Dose Study of VER-01 in Healthy Volunteers

Open-label Study to Evaluate the Pharmacokinetics and Safety of VER-01after Single and Multiple Administration of Different Doses to Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (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 in healthy volunteers

Detailed description

Determination of the single and multiple dose pharmacokinetic profile of VER-01 in healthy volunteers. Single dose: 6 subjects each will receive VER-01 corresponding to 2.5 mg (Group A), 5 mg (Group B), 10 mg (Group C) or 20 mg THC (Group D) in the morning. Multiple dose: 6 Subjects each receive VER-01 corresponding to 5 mg (Group E) or 10 mg (Group F) THC in the morning and in the evening on 4 consecutive days. A third group (Group G) receives VER-01 corresponding to 12.5 mg THC in the morning and 20 mg THC in the evening on 4 consecutive days.

Conditions

• Healthy

Interventions

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

Timeline

• Start date: 2021-11-25
• Primary completion: 2022-07-04
• Completion: 2022-07-11
• First posted: 2021-06-18
• Last updated: 2022-07-14

Locations

1 site across 1 country: Austria