PK in Healthy VolunteersPhase 1NCT07186283
Pharmacokinetic Study of a Novel Cannabidiol (CBD) Formulation in Healthy Volunteers
A Phase 1 study testing CBD soft-gel capsules 600 mg, CBD soft-gel capsules 900 mg and Epidyolex in people with PK in Healthy Volunteers, run by NW PharmaTech Ltd at 1 site in United Kingdom.
Trial summary
The purpose of this study is to test a new formulation of cannabidiol (CBD) to see how it is processed in the body and how safe it is for healthy volunteers. CBD is a compound found in the cannabis plant that has shown potential to help treat various medical and mental health conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- PK in Healthy Volunteers
- What is being tested?
- CBD soft-gel capsules 600 mg, CBD soft-gel capsules 900 mg and Epidyolex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Sep 2025to 10 Dec 2025
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female volunteers.
- Age range between 18 and 55 years old.
- Weight at least 50kg and have a body mass index (BMI) between 19 and 30 kg/m2 at screening.
- Willingness to comply with and complete all study procedures, including consuming the protocol specified high-fat, high-calorie meal in 30 minutes.
- In good health, as determined by no clinically significant findings from medical history, 12-lead ECG and vital signs measurements, and clinical laboratory evaluations at screening and check-in, and from the physical examination at screening and symptom-directed physical examination at baseline, as assessed by the investigator or designee.
- Abstinence from consuming St John's wort, grapefruit (juice), alcohol or tobacco and nicotine products for at least 72 hours prior to dosing and throughout treatment period.
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- Abstinence from caffeine for the duration of the in-clinic confinement period, including all dosing days. Caffeinated beverages and products will not be available on site.
- Capable and willing to comply with protocol requirements during the study.
- Participant is willing and able to give informed consent for participation in the study.
Who cannot join
- Participation in a research clinical trial within 90 days prior to Day 1 of the first experimental period, or 5 elimination half-lives prior to Day 1 of the first experimental period (whichever is longer) to Day 1, or throughout the study.
- Use of cannabis products, including hemp, in any form (including medication, oils, edibles or drinks) during the last 28 days before screening.
- History of hypersensitivity or allergy to CBD oil, sesame oil, hemp or any other cannabinoid products, or any of the items that could be included in the standardized meals/snacks.
- Using any regular medication in the 28 days prior to screening and throughout the study (as required doses of paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs) are permitted).
- Abnormal screening sample: clinically significant liver, renal or haematological abnormalities, including total Bilirubin, ALT or AST > the upper limit of normal (ULN).
- Positive screening test indicating active infection with HIV, hepatitis B virus or hepatitis C virus. Participants with evidence of past HBV infection and complete recovery may be eligible, at the discretion of the Investigator, provided liver function tests are within normal limits and there is no evidence of active infection.
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- Positive urine drug sample, including THC, at screening and, baseline excluding THC at post-dose.
- Positive alcohol breathalyser test at screening and throughout the study.
- Any suicidal ideation or behaviour in the past 12 months as assessed by responses to Columbia Suicidal Severity Rating questionnaire at screening.
- Any history of mental disorder including major depressive disorder, bipolar disorder, psychosis, and any current substance use disorder, including alcohol and tobacco use disorder.
- Any self-reported, observed or assessed medical condition that might put the subject at risk according to the physician's opinion.
- Any significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data.
- Participants with a sitting blood pressure at screening, after resting for 5 minutes, higher than 140/90 mmHg or lower than 90/50 mmHg.
- Blood donation or loss (eg surgery) over 200 ml in 3 months prior to screening and throughout study (menstruation is acceptable).
- Male participants not willing to use contraceptive methods throughout the study.
- Female participants who are pregnant (positive B-hCG urine test), lactating or breastfeeding.
- Female participants of childbearing potential* and not willing to use highly effective contraceptive methods** at screening or throughout the study.
- Defined as females who have experienced menarche and are not surgically sterilised (eg hysterectomy, bilateral salpingectomy) or post-menopausal.
- Highly effective methods of birth control are those with a failure rate <1% per year and include combined oestrogen and progesterone hormonal contraception, progestogen-only hormonal contraception, intrauterine devices (IUD), intrauterine hormone-releasing systems (IUS) and vasectomised partner.
- Participants with planned surgical or medical treatment requiring hospitalisation during the study.
- Employees or family members of the Sponsor.
- Participant unable to communicate reliably with research team.
- Participant is not able to swallow capsules.
- Subject unable or unwilling to consume the protocol specified high fat meal required by the trial protocol and/or the soft gel capsules, which contain gelatine of bovine origin, and/or Epidyolex which contains sesame oil and ethanol.
- Subjects with alcohol consumption > 14U/ week.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Fortrea Clinical Research Unit (Drapers Yard)
Leeds, West Yorkshire, LS11 9EH
About this study
Official title: A Phase 1 Study to Assess the Safety and Pharmacokinetics of Novel Cannabidiol (CBD) Soft-gel Capsule Formulation (NW300EMCBD) in Healthy Subjects
The purpose of this study is to test a new formulation of cannabidiol (CBD) to see how it is processed in the body and how safe it is for healthy volunteers. CBD is a compound found in the cannabis plant that has shown potential to help treat various medical and mental health conditions. While there is already an approved CBD-based drug that is used for epilepsy in the UK, called Epidyolex, most CBD formulations have poor absorption when taken orally, reducing their effectiveness and often requiring higher doses.
NW PharmaTech has developed a new CBD formulation aimed at improving absorption and processing by the body. This study will assess the absorption, safety, and tolerability of two different doses (600 mg and 900 mg) of the new formulation and will compare them with Epidyolex (dosed as per approved label).
Read more
All participants will receive each of the following three dosing regimens in a randomised order across three separate experimental periods, with each period separated by a 25 day washout period, which ensures that the drug from one dosing regimen is fully cleared from your body before the next dosing regimen begins.
Regimen A: 600 mg of the new CBD formulation (NW300EMCBD) administered orally Regimen B: 900 mg of the new CBD formulation (NW300EMCBD) administered orally Regimen C: 25 mg/kg Epidyolex solution (2 x 12.5 mg/kg doses separated by 12 hours) administered orally In total, participants will complete three dosing visits (one per experimental period), each spaced 25 days apart. The study will evaluate the pharmacokinetics (PK) of the formulations, which refers to how the body absorbs, distributes, metabolizes, and eliminates the drugs.
- Conditions
- PK in Healthy Volunteers
- Being tested
- CBD soft-gel capsules 600 mg, CBD soft-gel capsules 900 mg, Epidyolex
- Keywords
- Cannabidiol formulation, Cannabidiol pharmacokinetic, Encapsulated Micellar CBD formulation, Cannabidiol safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBD soft-gel capsules 600 mgDrug
600 mg
CBD soft-gel capsules 900 mgDrug
900 mg
EpidyolexDrug
25 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| NW300EMCBD 600 mg | Experimental | 600 mg CBD soft-gel capsules (novel formulation) Receives: Drug: CBD soft-gel capsules 600 mg |
| NW300EMCBD 900 mg | Experimental | 900 mg CBD soft-gel capsules (novel formulation) Receives: Drug: CBD soft-gel capsules 900 mg |
| Epidyolex | Active comparator | 25 mg/kg Receives: Drug: Epidyolex |
What is being measured
The primary outcome is the main question the study is designed to answer.
CBD plasma concentration
Difference in CBD plasma concentration between the novel formulation and Epidyolex
Measured: Pre-dose up to 192 hours post dose
Secondary outcomes (18)
Total Area Under the Curve (AUCinf)
Difference in CBD total exposure between the novel formulation and Epidyolex
Measured: Pre-dose up to 192 hours post dose
Total Area Under the Curve (AUCt)
Difference in CBD total exposure between the novel formulation and Epidyolex
Measured: Pre-dose up to 192 hours post dose
Dose-normalised Total Area Under the Curve (AUCinf/D)
Difference in CBD total exposure normalised by administered CBD total dose between the novel formulation and Epidyolex
Measured: Pre-dose up to 192 hours post dose
Cmax
Maximum plasma concentration
Measured: Pre-dose up to 192 hours post dose
Tmax
Time to reach maximum plasma concentration
Measured: Pre-dose up to 192 hours post dose
Plasma Half-life (t½)
Time to reduce the plasma concentration by half
Measured: Pre-dose up to 192 hours post dose
Apparent plasma clearance (CL/F)
Measured: Pre-dose up to 192 hours post dose
Apparent volume of distribution (Vz/F)
Measured: Pre-dose up to 192 hours post dose
Elimination rate constant (Kel)
Measured: Pre-dose up to 192 hours post dose
Number of participants with Adverse Events (AEs)
Measured: Pre-dose up to 192 hours post dose
Changes from pre-dose baseline in laboratory findings
laboratory sampling
Measured: Pre-dose up to 192 hours post dose
Changes from pre-dose baseline Blood Pressure (BP)
Measured: Pre-dose up to 192 hours post dose
Changes from pre-dose baseline in Heart Rate (HR)
Measured: Pre-dose up to 192 hours post dose
Changes from pre-dose baseline in vital signs Respiratory Rate
Measured: Pre-dose up to 192 hours post dose
Changes from pre-dose baseline in Body Temperature
Measured: Pre-dose up to 192 hours post dose
Number of participants with ECG findings
Measured: Pre-dose up to 192 hours post dose
Changes from pre-dose baseline iGastrointestinal Symptom Rating Scale (GSRS) score
The GSRS is a 15-item rating scale, where each item is assessed with a 7-point Likert scale, with higher scores indicating more severe symptoms.
Measured: Pre-dose to 24 hours post dose
Number of participants with suicidal ideation and/or behavior as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician administered assessment tool that evaluates suicidal ideation and behavior. Number of participants that have an affirmative response provided to the 5 items for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods (not plan) without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and/or to the 6 items for suicidal behavior (1. Actual attempt, 2. Interrupted attempt, 3. Aborted attempt, 4. Preparatory acts or behavior, 5. Suicidal Behavior 6. Completed suicide,) will be reported.
Measured: Pre-dose up to 192 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start22 Sep 2025
- Primary completion10 Dec 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PK in Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- NW PharmaTech Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186283
- Sponsor's protocol ID
- NWPharma_CH_001
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Assess the Safety and Pharmacokinetics of Novel Cannabidiol (CBD) Soft-gel Capsule Formulation (NW300EMCBD) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07186283
- Acronym / sponsor ID
- NWPharma_CH_001
- Conditions
- PK in Healthy Volunteers
- Keywords
- Cannabidiol formulation, Cannabidiol pharmacokinetic, Encapsulated Micellar CBD formulation, Cannabidiol safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- NW PharmaTech LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 22 Sep 2025 (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 purpose of this study is to test a new formulation of cannabidiol (CBD) to see how it is processed in the body and how safe it is for healthy volunteers. CBD is a compound found in the cannabis plant that has shown potential to help treat various medical and mental health conditions. While there is already an approved CBD-based drug that is used for epilepsy in the UK, called Epidyolex, most CBD formulations have poor absorption when taken orally, reducing their effectiveness and often requiring higher doses.
NW PharmaTech has developed a new CBD formulation aimed at improving absorption and processing by the body. This study will assess the absorption, safety, and tolerability of two different doses (600 mg and 900 mg) of the new formulation and will compare them with Epidyolex (dosed as per approved label).
All participants will receive each of the following three dosing regimens in a randomised order across three separate experimental periods, with each period separated by a 25 day washout period, which ensures that the drug from one dosing regimen is fully cleared from your body before the next dosing regimen begins.
Regimen A: 600 mg of the new CBD formulation (NW300EMCBD) administered orally Regimen B: 900 mg of the new CBD formulation (NW300EMCBD) administered orally Regimen C: 25 mg/kg Epidyolex solution (2 x 12.5 mg/kg doses separated by 12 hours) administered orally In total, participants will complete three dosing visits (one per experimental period), each spaced 25 days apart. The study will evaluate the pharmacokinetics (PK) of the formulations, which refers to how the body absorbs, distributes, metabolizes, and eliminates the drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NW300EMCBD 600 mg | Experimental | Drug: CBD soft-gel capsules 600 mg600 mg CBD soft-gel capsules (novel formulation) |
| NW300EMCBD 900 mg | Experimental | Drug: CBD soft-gel capsules 900 mg900 mg CBD soft-gel capsules (novel formulation) |
| Epidyolex | Active comparator | Drug: Epidyolex25 mg/kg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy male or female volunteers.
- Age range between 18 and 55 years old.
- Weight at least 50kg and have a body mass index (BMI) between 19 and 30 kg/m2 at screening.
- Willingness to comply with and complete all study procedures, including consuming the protocol specified high-fat, high-calorie meal in 30 minutes.
- In good health, as determined by no clinically significant findings from medical history, 12-lead ECG and vital signs measurements, and clinical laboratory evaluations at screening and check-in, and from the physical examination at screening and symptom-directed physical examination at baseline, as assessed by the investigator or designee.
Key exclusion criteria (25 listed)
- Participation in a research clinical trial within 90 days prior to Day 1 of the first experimental period, or 5 elimination half-lives prior to Day 1 of the first experimental period (whichever is longer) to Day 1, or throughout the study.
- Use of cannabis products, including hemp, in any form (including medication, oils, edibles or drinks) during the last 28 days before screening.
- History of hypersensitivity or allergy to CBD oil, sesame oil, hemp or any other cannabinoid products, or any of the items that could be included in the standardized meals/snacks.
- Using any regular medication in the 28 days prior to screening and throughout the study (as required doses of paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs) are permitted).
- Abnormal screening sample: clinically significant liver, renal or haematological abnormalities, including total Bilirubin, ALT or AST > the upper limit of normal (ULN).
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 |
|---|---|---|
| CBD soft-gel capsules 600 mg600 mg | Drug | NW300EMCBD 600 mg |
| CBD soft-gel capsules 900 mg900 mg | Drug | NW300EMCBD 900 mg |
| Epidyolex25 mg/kg | Drug | Epidyolex |
Primary outcome
CBD plasma concentration
Time frame: Pre-dose up to 192 hours post dose
Difference in CBD plasma concentration between the novel formulation and Epidyolex
18 secondary outcomes
Total Area Under the Curve (AUCinf)
Time frame: Pre-dose up to 192 hours post dose
Total Area Under the Curve (AUCt)
Time frame: Pre-dose up to 192 hours post dose
Dose-normalised Total Area Under the Curve (AUCinf/D)
Time frame: Pre-dose up to 192 hours post dose
Cmax
Time frame: Pre-dose up to 192 hours post dose
Tmax
Time frame: Pre-dose up to 192 hours post dose
Plasma Half-life (t½)
Time frame: Pre-dose up to 192 hours post dose
Apparent plasma clearance (CL/F)
Time frame: Pre-dose up to 192 hours post dose
Apparent volume of distribution (Vz/F)
Time frame: Pre-dose up to 192 hours post dose
Elimination rate constant (Kel)
Time frame: Pre-dose up to 192 hours post dose
Number of participants with Adverse Events (AEs)
Time frame: Pre-dose up to 192 hours post dose
Changes from pre-dose baseline in laboratory findings
Time frame: Pre-dose up to 192 hours post dose
Changes from pre-dose baseline Blood Pressure (BP)
Time frame: Pre-dose up to 192 hours post dose
Changes from pre-dose baseline in Heart Rate (HR)
Time frame: Pre-dose up to 192 hours post dose
Changes from pre-dose baseline in vital signs Respiratory Rate
Time frame: Pre-dose up to 192 hours post dose
Changes from pre-dose baseline in Body Temperature
Time frame: Pre-dose up to 192 hours post dose
Number of participants with ECG findings
Time frame: Pre-dose up to 192 hours post dose
Changes from pre-dose baseline iGastrointestinal Symptom Rating Scale (GSRS) score
Time frame: Pre-dose to 24 hours post dose
Number of participants with suicidal ideation and/or behavior as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Pre-dose up to 192 hours post dose
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 2 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 CBD soft-gel capsules 600 mg, CBD soft-gel capsules 900 mg and Epidyolex in people with PK in Healthy Volunteers, run by NW PharmaTech Ltd at 1 site in United Kingdom.
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 9 inclusion and 25 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 2 Feb 2026. 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 Kingdom. 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?
CBD plasma concentration (time frame: Pre-dose up to 192 hours post dose). 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 2 Feb 2026.