Investigation of the Pharmacokinetic Profile of CBD - Phase 1 ANANDA

NCT05023070 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: STUDY-19-02132
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Cannabidiol; Epidiolex; Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Safety and adverse effects

  Safety and adverse effects will be assessed with the Systematic Assessment for Treatment Emergent Events (SAFTEE).

  Study Visit 1 Day

• Peak plasma concentration (Cmax)

  Peak plasma concentration of CBD and its metabolites

  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 curve (AUC)

  Area under the plasma concentration versus time curve

  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.

Secondary Outcomes (2)

• Peak urine concentration of CBD (Umax)

  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 curve (AUC)

  Time point -60 minutes and 2, 4, 6, 8, 10, 12, 24 hours associated with administration of the CBD capsules.

Study Arms (4)

Test condition 1

EXPERIMENTAL

Cannabidiol 200 mg with standard meal

Drug: Cannabidiol

Test condition 2

EXPERIMENTAL

Cannabidiol 400 mg with standard meal

Drug: Cannabidiol

Test condition 3

EXPERIMENTAL

Epidiolex 400 mg with standard meal

Drug: Cannabidiol

Test condition 4

EXPERIMENTAL

Cannabidiol 400 mg with high fat meal

Drug: Cannabidiol

Interventions

Cannabidiol DRUG

Cannabidiol 200 mg

Also known as: Nantheia ATL5

Test condition 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and give informed consent;
• Individuals between 18 and 65 years old; Sex is used a biological factor (50% of individuals recruited will be females, allowing sex comparisons).
• English speakers.
• 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.
• Healthy volunteers who are medication- and drug-free, including free from nicotine and any prescribed medications.

You may not qualify if:

• 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
• 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);
• Positive urine drug screen (cocaine, opiates, benzodiazepines, barbiturates, amphetamines, morphine, methadone, methamphetamines, oxycodone, phencyclidine, tricyclic antidepressant, tetrahydrocannabinol, buprenorphine, methylenedioxymethamphetamine, propoxyphene);
• Having a history of hypersensitivity to cannabinoids or any of the ingredients in the product (gelatin and/or sesame oil);
• Being pregnant or breastfeeding;
• 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);
• Participating in another pharmacotherapeutic trial in the past 3 months;
• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Interventions

Cannabidiol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Yasmin Hurd

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: This is an open cross-over design study in healthy individuals to confirm the safety and pharmacokinetic (PK) effects of cannabidiol.

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 26, 2021
• Study Start: July 22, 2021
• Primary Completion: February 16, 2023
• Study Completion: February 16, 2023
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

US (1)