HealthyPhase 1NCT05023070
Investigation of the Pharmacokinetic Profile of CBD - Phase 1 ANANDA
A Phase 1 study testing Cannabidiol in people with Healthy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cannabidiol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2021to 16 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- Participating in another pharmacotherapeutic trial in the past 3 months;
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Investigation of the Pharmacokinetic Profile of CBD
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.
Read the 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:
- 200 mg CBD (standard meal)
- 400 mg CBD (standard meal)
- 400 mg Epidiolex (standard meal)
- 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
- Being tested
- Cannabidiol
- Keywords
- Cannabidiol, Epidiolex, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called Nantheia ATL5
Cannabidiol 200 mg
CannabidiolDrug
Also called Nantheia ATL5
Cannabidiol 400 mg
CannabidiolDrug
Also called Epidiolex
Epidiolex 400 mg
CannabidiolDrug
Also called Nantheia ATL5
Cannabidiol 400 mg
| Study group | Role | What they receive |
|---|---|---|
| Test condition 1 | Experimental | Cannabidiol 200 mg with standard meal Receives: Drug: Cannabidiol |
| Test condition 2 | Experimental | Cannabidiol 400 mg with standard meal Receives: Drug: Cannabidiol |
| Test condition 3 | Experimental | Epidiolex 400 mg with standard meal Receives: Drug: Cannabidiol |
| Test condition 4 | Experimental | Cannabidiol 400 mg with high fat meal Receives: Drug: Cannabidiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse effects
Safety and adverse effects will be assessed with the Systematic Assessment for Treatment Emergent Events (SAFTEE).
Measured: Study Visit 1 Day
Peak plasma concentration (Cmax)
Peak plasma concentration of CBD and its metabolites
Measured: 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
Measured: 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)
Peak urinary excretion of CBD and its metabolites
Measured: 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)
Area under the urine concentration versus time curve
Measured: Time point -60 minutes and 2, 4, 6, 8, 10, 12, 24 hours associated with administration of the CBD capsules.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start22 Jul 2021
- Primary completion16 Feb 2023
- Study completion16 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Hurd, Icahn School of Medicine at Mount Sinai
- Investigators
- Yasmin Hurd, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023070
- Sponsor's protocol ID
- STUDY-19-02132
- Status last verified
- Sep 2025
- First submitted
- 27 Jul 2021
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Pharmacokinetic Profile of CBD
- ClinicalTrials.gov ID
- NCT05023070
- Acronym / sponsor ID
- STUDY-19-02132
- Conditions
- Healthy
- Keywords
- Cannabidiol, Epidiolex, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 16 Feb 2023 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 26 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 200 mg CBD (standard meal)
- 400 mg CBD (standard meal)
- 400 mg Epidiolex (standard meal)
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is an open cross-over design study in healthy individuals to confirm the safety and pharmacokinetic (PK) effects of cannabidiol.
| Arm | Type | Receives |
|---|---|---|
| Test condition 1 | Experimental | Drug: CannabidiolCannabidiol 200 mg with standard meal |
| Test condition 2 | Experimental | Drug: CannabidiolCannabidiol 400 mg with standard meal |
| Test condition 3 | Experimental | Drug: CannabidiolEpidiolex 400 mg with standard meal |
| Test condition 4 | Experimental | Drug: CannabidiolCannabidiol 400 mg with high fat meal |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabidiolAlso: Nantheia ATL5Cannabidiol 200 mg | Drug | Test condition 1 |
| CannabidiolAlso: Nantheia ATL5Cannabidiol 400 mg | Drug | Test condition 2 |
| CannabidiolAlso: EpidiolexEpidiolex 400 mg | Drug | Test condition 3 |
| CannabidiolAlso: Nantheia ATL5Cannabidiol 400 mg | Drug | Test condition 4 |
Primary outcome
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).
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
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
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasmin Hurd principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cannabidiol in people with Healthy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse effects (time frame: Study Visit 1 Day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.