Effects of a Hemp Product on the Pharmacokinetics and Pharmacodynamics of Clopidogrel

NCT06692933 | Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: 20533U54AT008909
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine how two different doses of cannabidiol (CBD), given as a hemp product, change the blood concentrations of the drug clopidogrel in the body. Results will be used to help design future studies and to assist healthcare providers in informing their patients about the safe use of CBD.

Conditions

Interaction

Keywords

CYP2C19; pharmacokinetics; hemp; CBD; natural product; clopidogrel

Outcome Measures

Primary Outcomes (1)

• AUC ratio of clopidogrel active metabolite

  Ratio of the area under the plasma concentration vs. time curve of the active metabolite of clopidogrel in the presence to absence of hemp

  0-24 hours

Secondary Outcomes (2)

• Cannabidiol AUC

  0-72 hours

• AUC of cannabidiol metabolites

  0-72 hours

Study Arms (3)

Arm 1: clopidogrel alone

EXPERIMENTAL

Participants will be administered a single oral dose (75 mg) of clopidogrel. Blood and urine will be collected for 24 hours.

Drug: Clopidogrel

Arm 2: chronic hemp (30 mg CBD) + clopidogrel

EXPERIMENTAL

Participants will self-administer a single low dose of hemp (30 mg CBD) as an oral softgel at home daily for 5 consecutive days. On day 6, participants will return to the research setting, where they will be administered a single low dose of hemp (30 mg CBD) and a single oral dose of clopidogrel (75 mg). Blood will be collected for 72 hours and urine will be collected for 24 hours.

Drug: Cannabidiol in the form of hemp; Drug: Clopidogrel

Arm 3: chronic hemp (240 mg CBD) + clopidogrel

EXPERIMENTAL

Participants will repeat the Arm 2 procedures using a higher dose of hemp (240 mg CBD)

Drug: Cannabidiol in the form of hemp; Drug: Clopidogrel

Interventions

Cannabidiol in the form of hemp DRUG

Cannabidiol (30 mg) in the form of an orally administered hemp oil softgel

Also known as: CBD

Arm 2: chronic hemp (30 mg CBD) + clopidogrel; Arm 3: chronic hemp (240 mg CBD) + clopidogrel

Clopidogrel DRUG

75 mg oral clopidogrel

Also known as: Plavix

Arm 1: clopidogrel alone; Arm 2: chronic hemp (30 mg CBD) + clopidogrel; Arm 3: chronic hemp (240 mg CBD) + clopidogrel

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old and healthy;
• Confirmed by genetic test to be a CYP2C19 normal, rapid, or ultra-rapid metabolizer;
• Not taking any medications (prescription and non-prescription, including clopidogrel) or dietary supplements/botanical products known to alter the pharmacokinetics of cannabis and/or clopidogrel;
• Have taken hemp or cannabis (in any form) before and tolerated it well;
• Willing to abstain from consuming dietary supplements/botanical products and citrus juices for the duration of the study;
• Willing to abstain from cannabis/marijuana, hemp, THC- and/or CBD-containing products for several weeks;
• Willing to abstain from consuming caffeinated beverages or other caffeine-containing products the evening before and morning of any inpatient day;
• Willing to abstain from consuming alcoholic beverages for one day prior to any inpatient day;
• Willing to use a secondary method of birth control that does not include the introduction or discontinuance of hormonal-based birth control (such as abstinence, copper IUD, or condoms), continuing for 1 week after completing the study;
• Have the ability to and are willing to comply with the requirements of the study;
• Geographically located within a 40-mile radius of Spokane and have the time to participate and;
• Can read and speak English

You may not qualify if:

• Under the age of 21 or over the age of 64;
• Any major illness;
• Pregnant or nursing;
• History of allergy or intolerance to cannabis or clopidogrel;
• Taking concomitant medications, both prescription and non-prescription (including clopidogrel) or dietary supplements/botanical products known to alter the pharmacokinetics of cannabis and/or clopidogrel;
• Never taken cannabis (in any form) before;
• Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise participant safety or the quality of the data;
• Currently using or have recently used drugs or other illicit substances for recreational purposes;
• Have used cannabis/marijuana, hemp, THC- and/or CBD-containing products within the last 4 weeks;
• Have an out-of-range clinical laboratory value such that the study physician considers participation in the study a health risk, or;
• Unable to read and speak English

Sponsors & Collaborators

• Washington State University: lead
• Office of Dietary Supplements (ODS): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Washington State University College of Pharmacy and Pharmaceutical Sciences

Spokane, Washington, 99202, United States

RECRUITING

MeSH Terms

Interventions

Cannabidiol; Clopidogrel

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Mary F Paine, RPh, PhD

CONTACT

509-358-7759; mary.paine@wsu.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: June 20, 2024
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)