Investigation of the Pharmacokinetic Profile of CBD - Phase 1 ANANDA

NCT ID: NCT05023070

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-22
• Study Completion Date: 2023-02-16

Brief Summary

The goal of the current study is to evaluate the bioavailability 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.

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Test condition 1

Cannabidiol 200 mg with standard meal

Group Type: EXPERIMENTAL

Cannabidiol

Intervention Type: DRUG

Cannabidiol 200 mg

Test condition 2

Cannabidiol 400 mg with standard meal

Group Type: EXPERIMENTAL

Cannabidiol

Intervention Type: DRUG

Cannabidiol 400 mg

Test condition 3

Epidiolex 400 mg with standard meal

Group Type: EXPERIMENTAL

Cannabidiol

Intervention Type: DRUG

Epidiolex 400 mg

Test condition 4

Cannabidiol 400 mg with high fat meal

Group Type: EXPERIMENTAL

Cannabidiol

Intervention Type: DRUG

Cannabidiol 400 mg

Interventions

Cannabidiol

Cannabidiol 200 mg

Intervention Type: DRUG

Cannabidiol

Cannabidiol 400 mg

Intervention Type: DRUG

Cannabidiol

Epidiolex 400 mg

Intervention Type: DRUG

Cannabidiol

Cannabidiol 400 mg

Intervention Type: DRUG

Other Intervention Names

Nantheia ATL5; Nantheia ATL5; Epidiolex; Nantheia ATL5

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Yasmin Hurd

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yasmin Hurd

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

STUDY-19-02132

Identifier Type: -

Identifier Source: org_study_id