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Cannabidiol

CBD-NE Under Fed Condition for Healthy Subjects

Phase 1
Waitlist Available
Led By Anthony Bier, MD
Research Sponsored by DSM Nutritional Products, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Healthy male or female participants who are 19 to 55 years of age (inclusive).
2. Have a body mass index (BMI) range of 18.0 - 29.9 kg/m2 (inclusive) and body weight ≥ 50 kg.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up minimum of 14 days, maximum of 28 days
Awards & highlights

Summary

Cannabidiol (CBD), derived from the Cannabis sativa plant, is being investigated for its potential health benefit without the psychoactive properties and adverse reactions that arise from the use of delta-9-tetrahydrocannabinol (Δ9-THC). Few studies have characterized the pharmacokinetic (PK) effects and safety of oral CBD administration. Epidiolex (Epidyolex), an oil form of CBD, is the only marketed monotherapy approved by the United States Food and Drug Administration (FDA) and Health Canada. Delivery of a CBD in a powder/capsule form may provide a more efficient method for consumers. The goal of this study is to characterize the PK profile of the test product, CBD-NE (a capsule formulation) compared to Epidyolex under both fasted and fed conditions. Each participant will receive a dose of each product under both fed and fasted conditions in a crossover design.

Who is the study for?
This trial is for healthy adult volunteers interested in helping to study the effects of a new form of cannabidiol (CBD). Participants should be willing to take CBD under different eating conditions. Specific eligibility details are not provided, but typically include age range and health status requirements.
What is being tested?
The study is testing how a new capsule form of CBD called CBD-NE compares with Epidyolex, an FDA-approved oil-based CBD product. The test measures how the body absorbs each form when participants have eaten (fed) or haven't eaten (fasted), using a crossover design where everyone gets both treatments at different times.
What are the potential side effects?
While specific side effects aren't listed here, common ones associated with CBD may include tiredness, diarrhea, changes in appetite/weight, and possibly some liver issues. Since this trial involves healthy volunteers, monitoring for any adverse reactions will be part of the safety assessment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~minimum of 14 days, maximum of 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and minimum of 14 days, maximum of 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pharmacokinetic (PK) Properties of CBD-NE compared to Epidyolex under Fed Conditions
Secondary study objectives
PK Properties of CBD-NE compared to Epidiolex under Fed Conditions
PK Properties of CBD-NE compared to Epidyolex under Fasted Conditions
PK Properties of CBD-NE compared to Epidyolex under Fed Conditions
+2 more
Other study objectives
Assessment of 12-lead electrocardiogram (ECG)
Blood pressure
Body Temperature
+39 more

Side effects data

From 2015 Phase 3 trial • 120 Patients • NCT02091375
31%
Diarrhoea
31%
Somnolence
26%
Decreased appetite
18%
Fatigue
15%
Vomiting
15%
Pyrexia
11%
Upper respiratory tract infection
11%
Lethargy
8%
Convulsion
7%
Weight decreased
7%
Gamma-glutamyltransferase increased
7%
Irritability
7%
Cough
7%
Transaminases increased
5%
Status epilepticus
5%
Nasopharyngitis
2%
Oral herpes
2%
Pneumonia
2%
Platelet count
2%
Abdominal distension
2%
Abdominal pain
2%
Gastrointestinal haemorrhage
2%
Asthenia
2%
Lower respiratory tract infection
2%
Gamma-glutamyltransferase
2%
Hypophagia
2%
Hypotonia
2%
Myoclonus
2%
Respiratory failure
2%
Epistaxis
2%
Hypovolaemic shock
2%
Aspartate aminotransferase increased
2%
Liver function test abnormal
2%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
GWP42003-P 20 mg/kg/Day Dose
Placebo

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: TP Under Fasted ConditionExperimental Treatment1 Intervention
A single dose of CBD-NE (6 capsules) after a minimum 10-hour fast
Group II: CBD-NE Under Fed ConditionExperimental Treatment1 Intervention
A single dose of CBD-NE (6 capsules) following consumption of a high-fat, high-calorie breakfast
Group III: Epidyolex Under Fasted ConditionActive Control1 Intervention
A single dose of Epidyolex (4 mL oil) after a minimum 10-hour fast
Group IV: Epidyolex Under Fed ConditionActive Control1 Intervention
A single dose of Epidyolex (4 mL oil) following consumption of a high-fat, high-calorie breakfast

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

DSM Nutritional Products, Inc.Lead Sponsor
96 Previous Clinical Trials
57,506 Total Patients Enrolled
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.NETWORK
35 Previous Clinical Trials
1,982 Total Patients Enrolled
Anthony Bier, MDPrincipal InvestigatorApex Trials
7 Previous Clinical Trials
326 Total Patients Enrolled
~16 spots leftby Dec 2024
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