NCT05049733

The Pharmacokinetics and Pharmacodynamics of a Single Acute Dose of a Hemp-derived Oral Product With a 1:1 Ratio of CBD:CBD-A

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to examine the pharmacokinetics and pharmacodynamics of a hemp-derived oral product containing cannabidiol (CBD) and cannabidiolic acid (CBD-A) at a 1:1 ratio.

Detailed description

The purpose of the present study is to examine the pharmacokinetics and pharmacodynamics of a novel hemp-derived oral cannabinoid product, at various doses, in healthy adults. The study will utilize a within-subjects, placebo-controlled, double-blind, ascending-dose design. Drug administration will be double blind (the participant and research staff will be unaware of the dose administered). Upon enrollment, participants will complete 4 dosing conditions (placebo, 1 mg/kg, 2 mg/kg, 4 mg/kg of cannabinoids). Each condition will consist of a single acute drug exposure, followed by an 8-hour period to evaluate acute pharmacodynamic and pharmacokinetic (PK) drug effects. Biological specimens (blood and urine) will be obtained throughout these 8 hours to characterize the pharmacokinetics of CBD, CBD-A, delta-9-Tetrahydrocannabinol (THC), and THC-A, as well as other relevant cannabinoids and metabolites. Pharmacodynamic assessments including subjective drug effects, cognitive performance testing, and vital signs will also be collected for 8 hours post-drug administration. For each of the two days after each experimental session, participants will be asked to return to the lab for brief visits (\~20 min) to provide additional biospecimens (\~24 and \~48 hrs after dosing) to allow for further PK analysis. These procedures will be completed 4 separate times by each participant (sessions will be separated by at least 1 week to allow for sufficient drug washout between doses).

Conditions

• Cannabis

Interventions

Type	Name	Description
DRUG	CBD 1mg/Kg	Participants will ingest soft gel tablets containing CBD 1mg/Kg
DRUG	CBD 2mg/Kg	Participants will ingest soft gel tablets containing CBD 2mg/Kg
DRUG	CBD 4mg/Kg	Participants will ingest soft gel tablets containing CBD 4mg/Kg
DRUG	Placebo CBD	Participants will ingest soft gel tablets containing placebo for CBD

Timeline

• Start date: 2022-03-07
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2021-09-20
• Last updated: 2023-06-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study