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Investigation of the Pharmacokinetic Profile of CBD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05023070
Recruitment Status : Active, not recruiting
First Posted : August 26, 2021
Last Update Posted : November 30, 2022
Sponsor:
Information provided by (Responsible Party):
Hurd,Yasmin, Ph.D.

Brief Summary:
The goal of the current study is to evaluate the bioavaibiltiy of CBD in normal healthy Individuals. This is an open cross-over design study in healthy individuals to assess the safety and pharmacokinetic (PK) effects of cannabidiol.

Condition or disease Intervention/treatment Phase
Healthy Drug: Cannabidiol Phase 1

Detailed Description:

The goal of this study is to determine the pharmacokinetics and pharmacodynamic profile of CBD in normal healthy individuals under standard and high fat fed conditions.

CBD has recently gained significant attention as a potential treatment for various disorders. One aspect for consideration in the development of CBD medication in capsule form is the poor bioavailability of cannabinoids such as CBD to obtain clinically effective doses since only ~4-6% of CBD is absorbed orally. This study will investigate the potential of CBD in a formulation in a capsule to enhance bioavailability, reduce the incidence of gastrointestinal side effects, reduce first pass metabolism and enhance onset time. This PK study will be conducted with standard meal and high fat conditions in normal healthy volunteers in a cross-over design, separated by a washout period of 1 week. Healthy volunteers are defined as having no significant health-related issues (i.e., the absence of significant medical, psychosocial, or emotional conditions) that are verified by clinical and psychiatric assessments.

The study will first evaluate in healthy volunteers the PK, tolerability and safety profiles of a new CBD formulation designed to improve bioavailability.

Test conditions and order:

  1. 200 mg CBD (standard meal)
  2. 400 mg CBD (standard meal)
  3. 400 mg Epidiolex (standard meal)
  4. 400 mg CBD (high fat meal)

Blood samples will be taken at -60,15, 30, 45 and 60 min and 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours associated with administration of the CBD capsules.

Monitoring period for PK: 24 hours (plasma and urine PK). Participation in 4 test conditions for a duration of approximately 4 weeks and a 1 week follow-up assessment. Total length of in-house stay is 12 hours, with participants returning the following day for 24 hour time point procedures.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is an open cross-over design study in healthy individuals to confirm the safety and pharmacokinetic (PK) effects of cannabidiol.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Investigation of the Pharmacokinetic Profile of CBD
Actual Study Start Date : July 22, 2021
Estimated Primary Completion Date : February 20, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

Arm Intervention/treatment
Experimental: Test condition 1
Cannabidiol 200 mg with standard meal
Drug: Cannabidiol
Cannabidiol 200 mg
Other Name: Nantheia ATL5

Experimental: Test condition 2
Cannabidiol 400 mg with standard meal
Drug: Cannabidiol
Cannabidiol 400 mg
Other Name: Nantheia ATL5

Experimental: Test condition 3
Epidiolex 400 mg with standard meal
Drug: Cannabidiol
Epidiolex 400 mg
Other Name: Epidiolex

Experimental: Test condition 4
Cannabidiol 400 mg with high fat meal
Drug: Cannabidiol
Cannabidiol 400 mg
Other Name: Nantheia ATL5




Primary Outcome Measures :
  1. Safety and adverse effects [ Time Frame: Study Visit 1 Day ]
    Safety and adverse effects will be assessed with the Systematic Assessment for Treatment Emergent Events (SAFTEE).

  2. Peak plasma concentration (Cmax) [ Time Frame: Time point -60,15, 30, 45 and 60 minutes and 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours associated with administration of the CBD capsules. ]
    Peak plasma concentration of CBD and its metabolites

  3. Area under the plasma concentration curve (AUC) [ Time Frame: Time point -60,15, 30, 45 and 60 minutes and 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours associated with administration of the CBD capsules. ]
    Area under the plasma concentration versus time curve


Secondary Outcome Measures :
  1. Peak urine concentration of CBD (Umax) [ Time Frame: Time point -60 minutes and 2, 4, 6, 8, 10, 12, 24 hours associated with administration of the CBD capsules. ]
    Peak urinary excretion of CBD and its metabolites

  2. Area under the urine concentration curve (AUC) [ Time Frame: Time point -60 minutes and 2, 4, 6, 8, 10, 12, 24 hours associated with administration of the CBD capsules. ]
    Area under the urine concentration versus time curve



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Ability to understand and give informed consent;
  2. Individuals between 18 and 65 years old; Sex is used a biological factor (50% of individuals recruited will be females, allowing sex comparisons).
  3. English speakers.
  4. Being healthy as determined by study physician according to screening medical and psychiatric history, physical examination, vitals, ECG and safety laboratory values. Only healthy volunteers with normal hepatic laboratory values will be enrolled.
  5. Healthy volunteers who are medication- and drug-free, including free from nicotine and any prescribed medications.

Exclusion Criteria:

  1. Having present or past medical conditions, including a DSM-5 Axis I psychiatric disorder, history of cardiac disease, arrhythmias, neurological disease of central origin, head trauma, and seizures
  2. Using any psychoactive drug (other than nicotine) in at least the past 7 days (determined by lack of acute-opioid or other drugs related withdrawal symptoms and the negative result of a urine drug screen including an opioid drug metabolite test, and alcohol breathalyzer to detect alcohol intoxication);
  3. Positive urine drug screen (cocaine, opiates, benzodiazepines, barbiturates, amphetamines, morphine, methadone, methamphetamines, oxycodone, phencyclidine, tricyclic antidepressant, tetrahydrocannabinol, buprenorphine, methylenedioxymethamphetamine, propoxyphene);
  4. Having a history of hypersensitivity to cannabinoids or any of the ingredients in the product (gelatin and/or sesame oil);
  5. Being pregnant or breastfeeding;
  6. Not using an appropriate method of contraception such as hormonal contraception (oral hormonal contraceptives, Depo-Provera, Nuva-Ring), intrauterine device (IUD), sterilization, or double barrier method (combination of any two barrier methods used simultaneously, i.e. condom, spermicide, diaphragm);
  7. Participating in another pharmacotherapeutic trial in the past 3 months;
  8. History of impaired renal function or elevated liver enzymes at prescreening. The exclusionary lab values are: 3x nl AST/ALT, 1.5x bilirubin or 50% reduction in eGFR.
  9. Participants who have used any medication, dietary supplements (and/or grape fruit juice), or combination of medications and supplements known to alter the metabolism of, or interact with CBD (bupropion, rifampin, barbiturates, phenothiazines, cimetidine, etc.) 14 days prior to and during the duration of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05023070


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Hurd,Yasmin, Ph.D.
Investigators
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Principal Investigator: Yasmin Hurd Icahn School of Medicine at Mount Sinai
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Responsible Party: Hurd,Yasmin, Ph.D.
ClinicalTrials.gov Identifier: NCT05023070    
Other Study ID Numbers: IRB-19-02132
First Posted: August 26, 2021    Key Record Dates
Last Update Posted: November 30, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hurd,Yasmin, Ph.D.:
Cannabidiol
Epidiolex
Healthy Volunteers
Additional relevant MeSH terms:
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Cannabidiol
Anticonvulsants