Liver Function, Metabolism, Pharmacokinetics
Conditions
Brief summary
According to a recent consumer poll, over 20 million Americans regularly use cannabidiol (CBD). Moreover, 64 million Americans (over 25% of the population) report trying CBD at least once within the previous 2 years. Since the passing of the 2018 Agriculture Improvement Act, the use of hemp-derived products, such as CBD, is highly prevalent across North America. The acceleration of the use of CBD has outpaced our understanding of the associated potential risks and benefits, and the way it is processed within the body. In the current proposed project, investigators wish to continue our ongoing collaboration with Caliper Foods, a Colorado-based manufacturer of CBD products. The focus of this project is three-fold: (1) investigators will compare the pharmacokinetics of different formulations of ingestible CBD; (2) investigators will examine the potential two-way interaction between a meal and one formulation of ingestible CBD; and, (3) investigators will examine the influence of different formulations of CBD on markers of liver function.
Detailed description
Pharmacokinetics describes the speed in which something that is ingested is made available within the body (i.e. bioavailability).There are many different preparations/formulations of CBD and they may differ from one another with regards to their pharmacokinetics. One important consideration when evaluating CBD formulations is the pharmacokinetic goal and intended use. For example, if the indication for the CBD is to treat acute pain, then a faster time to peak concentration (Tmax) and higher maximal concentration (Cmax) may be desirable, and also may help to decrease the risk of overdose due to premature repeat self administration. Alternatively, as a chronic treatment for anxiety, a larger area under the curve (AUC) may be preferable if a user follows a regular dosing schedule. One purpose of the proposed project is to compare the pharmacokinetics of different formulations of CBD. The formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). Several previous studies have demonstrated an influence of eating on the pharmacokinetics of ingested CBD. The general consensus appears to be that prior ingestion of a high-fat meal increases the maximal concentration of circulating CBD (Cmax) and lowers the time to attain peak circulating concentration (Tmax). One purpose of the proposed project is to study the influence of a standardized meal on the pharmacokinetics of a CBD formulation. Little is known about the influence of ingested CBD on postprandial metabolism. The thermic effect of feeding (i.e. the increase in metabolic rate above resting metabolism) is considered an important physiological determinant of energy balance, and therefore also of weight gain or loss. Further, the dynamics of circulating glucose and triglycerides following a meal are reflective of metabolic health and predictive of future cardiometabolic disease risk. CBD has been purported to have a variety of beneficial physiological properties, including anti-inflammatory and antioxidant actions. Either of these individual properties alone could favorably modify postprandial metabolism, given that CBD potentially does both, it appears likely that CBD might improve the physiological regulation of postprandial metabolism. One purpose of the proposed project is to determine the influence of CBD on postprandial metabolism. The liver plays a critical regulatory role in postprandial metabolism, and also with the physiological processing of cannabinoids. The relationship between the use of cannabinoids and liver health is unclear. While early studies implied that exposure of the liver to very high daily dosing of cannabinoids may be detrimental, more recent studies are suggesting that some cannabinoids, including CBD, may have therapeutic potential for the treatment of non-alcoholic fatty liver disease. The acute effects of low dose CBD (e.g. 30 mg) on liver function in healthy adults have not been well described, and may be influenced by the formulation of the CBD product (i.e. whether it is water or lipid soluble). One purpose of the proposed project is to determine the acute influence of different formulations of CBD on circulating markers of liver function.
Interventions
DIETARY_SUPPLEMENTCannabidiol (CBD) powder formulation
T-P-S-10 Caliper powder - 30 mg CBD in the form of 300 mg of 10% CBD isolate (Formulation 725: Water soluble.Contains sorbitol)
DIETARY_SUPPLEMENTCannabidiol (CBD) Oil based tincture formulation
30 mg CBD isolate in MCT oil,1:1 ratio of CBD to Medium Chain Triglycerides oil. (Formulation 088: Not water soluble. Contains medium chain triglyceride coconut oil.)
DIETARY_SUPPLEMENTCannabidiol (CBD) Gum Arabic, maltodextrin base formulation
10% CBD Gum Arabic, maltodextrin base(Formulation 126: Water soluble. Contains gum arabic and maltodextrin)
DIETARY_SUPPLEMENTCannabidiol (CBD) Gum Arabic, sorbitol base formulation
10% CBD Gum Arabic, sorbitol base (Formulation 213: Water soluble. Contains gum arabic and sorbitol)
DIETARY_SUPPLEMENTCannabidiol (CBD) Isolate in water formulation
Pure CBD as crystalline powder (\>99% purity) (Formulation 625 Not water soluble)
DIETARY_SUPPLEMENTCBD matching Placebo
Matching Placebo
Sponsors
Colorado State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Masking description
The CBD and placebo formulations are prepared, bottled and coded by Caliper Foods. The participants will receive a coded bottle to consume of the different formulations of CBD and placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participants must be greater than 18 years of age * Weigh more than 110 pounds * Have a body mass index greater than 25kg/m\^2 * Be free of any gastrointestinal or metabolic diseases * Be able to refrain from use of any Cannabis or cannabis containing products for three days prior to participating in the study.
Exclusion criteria
* Less than 18 years of age * Pregnant or breastfeeding * Food allergies * Autoimmune disorders or with compromised immune function, * Celiac disease * Inflammatory bowel Diseases * Gastrointestinal cancers * Diabetes * HIV * Adverse reactions to ingesting Cannabis spp. or cannabis-containing products (including, but not limited to, marijuana, CBD oils, or CBD/THC containing food products) * Taking any of the follow medications: steroids, HMG-CoA reductase inhibitors, calcium channel blockers, antihistamines, HIV antivirals, immune modulators, benzodiazepines, antiarrythmics, antibiotics, anesthetics, antipsychotics, antidepressants, anti-epileptics, beta blockers, proton pump inhibitors, NSAIDs, angiotension II blockers, oral hypoglycemic agents, and sulfonylureas.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic Time to Maximum Concentration- (Tmax) for Different Formulations of CBD | Venous blood will be sampled at standardized intervals: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Tmax (minutes). |
| Pharmacokinetic Maximum Concentration-(Cmax) for Different Formulations of CBD | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Cmax (ng/mL). |
| Pharmacokinetic Area Under the Curve Representing Total Cannabidiol Exposure Between 0 and 4 h (AUC 0-4) for Different Formulations of CBD | Venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate AUC 0-4 (min x ng/mL). |
| Pharmacokinetic Area Under the Curve an Estimate of Total Exposure to CBD Over Time (AUC 0-inf) for Different Formulations of CBD | Venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate AUC 0-inf (mins x ng/mL). |
| Pharmacokinetic Amount of Time it Takes to Decrease the Circulating Concentration to Half of Its Initial Value (t1/2) for Different Formulations of CBD | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate t1/2 (mins). |
| Pharmacokinetic Rate at Which CBD is Absorbed Into the Body (Ka) for Different Formulations of CBD | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Ka(1/h). |
| Pharmacokinetic Rate at Which CBD is Removed From the Body (Ke) for Different Formulations of CBD | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Ke (1/h). |
| CBD Pharmacokinetic Volume of Distribution- (Vd) for Different Formulations of CBD | Venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Vd (L). |
| Pharmacokinetic Parameter Tmax of a Formulation 725 After a Standardized Meal | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. | At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts the time to attain peak circulating concentration Tmax (mins). |
| Pharmacokinetic Parameter Cmax of a Formulation 725 After a Standardized Meal | venous blood will be sampled at standardized intervals over: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. | At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Cmax (ng/L). |
| Pharmacokinetic Parameter AUC 0-4 of Formulation 725 After a Standardized Meal | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. | At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD AUC 0-4 (min x ng/mL). |
| Pharmacokinetic Parameter AUC 0-inf of Formulation 725 After a Standardized Meal | venous blood will be sampled at standardized intervals 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. | At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD AUC 0-inf (min x ng/mL). |
| Pharmacokinetic Parameter t1/2 of Formulation 725 After a Standardized Meal | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. | At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD t1/2 (h). |
| Pharmacokinetic Parameter Ka of Formulation 725 After a Standardized Meal | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. | At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Ka (1/h). |
| Pharmacokinetic Parameter Ke of Formulation 725 After a Standardized Meal | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. | At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Ke (1/h). |
| Pharmacokinetic Parameter Vd of Formulation 725 After a Standardized Meal | venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration. | At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Vd (L). |
| Ingested CBD on Postprandial Metabolism Via Indirect Calorimetry | Randomized visit Including a test meal collected during 235 minutes of TEF | At the 2 randomized visits Including a Test Meal Thermic Effect of Feeding (TEF) Under the Curve was calculated from standardized intervals prior to and after ingestion of a liquid meal and a single dose of Formulation 725. |
| Ingested CBD on Postprandial Metabolism Via Measurements of Glucose | Compare 2 randomized visits Including a test meal collected at baseline,10,20,30,45,60,90,120,150,180,210, and 240 minutes. | At the 2 randomized visits Including a Test Meal, glucose Area Under the Curve was calculated from standardized intervals after ingestion of a liquid meal and a single dose of Formulation 725. |
| Ingested CBD on Postprandial Metabolism Via Measurements of Insulin | Compare 2 randomized visits Including a test meal collected at baseline,10,20,30,45,60,90,120,150,180,210, and 240 minutes. | At the 2 randomized visits Including a Test Meal insulin Area Under the Curve was calculated from standardized intervals after ingestion of a liquid meal and a single dose of Formulation 725. |
| Ingested CBD on Postprandial Metabolism Via Measurements of Triglycerides | Compare 2 randomized visits Including a test meal collected at baseline,10,20,30,45,60,90,120,150,180,210, and 240 minutes. | At the 2 randomized visits Including a Test Meal triglyceride Area Under the Curve was calculated from standardized intervals after ingestion of a liquid meal and a single dose of Formulation 725. |
| Acute Influence of Liver Function, Alanine Aminotransferase (ALT), With the Different Formulations of CBD. | Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for alanine aminotransferase (ALT). |
| Acute Influence of Liver Function, Albumin, for Different Formulations of CBD. | Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for albumin. |
| Acute Influence of Liver Function, Alkaline Phosphatase, With the Different Formulations of CBD. | Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for alkaline phosphatase. |
| Acute Influence of Liver Function, Aspartate Aminotransferase, With the Different Formulations of CBD. | Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for aspartate aminotransferase. |
| Acute Influence of Liver Function, Total Bilirubin, With the Different Formulations of CBD. | Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for total bilirubin. |
| Acute Influence of Kidney Function, Blood Urea, With the Different Formulations of CBD. | Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days | The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for blood urea. |
| CBD on Postprandial Metabolism Via Indirect Calorimetry | Compare 2 randomized visits Including a test meal collected during 45 minutes of resting metabolic rate | At the 2 randomized visits including a Resting Metabolic Rate prior to and after ingestion of a single dose of Formulation 725 or placebo. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Over Number of Study Participants Randomized Cross over study | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | BMI too low | 9 |
| Overall Study | Discontinued scheduling conflict | 1 |
| Overall Study | geographic location | 1 |
| Overall Study | Long Term Illness | 1 |
Baseline characteristics
| Characteristic | Over Number of Study Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 26 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 26 participants | — |
| Sex: Female, Male Female | 9 Participants | — |
| Sex: Female, Male Male | 17 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 |
Outcome results
Primary
Acute Influence of Kidney Function, Blood Urea, With the Different Formulations of CBD.
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for blood urea.
Time frame: Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Formulation 088 | Acute Influence of Kidney Function, Blood Urea, With the Different Formulations of CBD. | 60 minutes | 14.6 mg/dL | Standard Deviation 2.9 |
| Formulation 088 | Acute Influence of Kidney Function, Blood Urea, With the Different Formulations of CBD. | 0 minutes | 15.1 mg/dL | Standard Deviation 2.7 |
| Formulation 088 | Acute Influence of Kidney Function, Blood Urea, With the Different Formulations of CBD. | 240 minutes | 13.9 mg/dL | Standard Deviation 2.5 |
| Formulation 126 | Acute Influence of Kidney Function, Blood Urea, With the Different Formulations of CBD. | 60 minutes | 14.4 mg/dL | Standard Deviation 2.8 |
| Formulation 126 | Acute Influence of Kidney Function, Blood Urea, With the Different Formulations of CBD. | 0 minutes | 14.6 mg/dL | Standard Deviation 2.8 |
| Formulation 126 | Acute Influence of Kidney Function, Blood Urea, With the Different Formulations of CBD. | 240 minutes | 13.4 mg/dL | Standard Deviation 2.5 |
| Formulation 213 | Acute Influence of Kidney Function, Blood Urea, With the Different Formulations of CBD. | 60 minutes | 15.1 mg/dL | Standard Deviation 4.6 |
| Formulation 213 | Acute Influence of Kidney Function, Blood Urea, With the Different Formulations of CBD. | 0 minutes | 15.4 mg/dL | Standard Deviation 4.5 |
| Formulation 213 | Acute Influence of Kidney Function, Blood Urea, With the Different Formulations of CBD. | 240 minutes | 14 mg/dL | Standard Deviation 4.2 |
| Formulation 625 | Acute Influence of Kidney Function, Blood Urea, With the Different Formulations of CBD. | 60 minutes | 15.5 mg/dL | Standard Deviation 4.1 |
| Formulation 625 | Acute Influence of Kidney Function, Blood Urea, With the Different Formulations of CBD. | 0 minutes | 15.4 mg/dL | Standard Deviation 3.9 |
| Formulation 625 | Acute Influence of Kidney Function, Blood Urea, With the Different Formulations of CBD. | 240 minutes | 14.3 mg/dL | Standard Deviation 3.5 |
| Formulation 725 | Acute Influence of Kidney Function, Blood Urea, With the Different Formulations of CBD. | 60 minutes | 14.8 mg/dL | Standard Deviation 3.9 |
| Formulation 725 | Acute Influence of Kidney Function, Blood Urea, With the Different Formulations of CBD. | 0 minutes | 15 mg/dL | Standard Deviation 3.6 |
| Formulation 725 | Acute Influence of Kidney Function, Blood Urea, With the Different Formulations of CBD. | 240 minutes | 13.8 mg/dL | Standard Deviation 3.7 |
| Formulation 725 | Acute Influence of Kidney Function, Blood Urea, With the Different Formulations of CBD. | 0 minutes | 15.9 mg/dL | Standard Deviation 3.3 |
| Formulation 725 | Acute Influence of Kidney Function, Blood Urea, With the Different Formulations of CBD. | 240 minutes | 14.1 mg/dL | Standard Deviation 3.1 |
| Formulation 725 | Acute Influence of Kidney Function, Blood Urea, With the Different Formulations of CBD. | 60 minutes | 15.3 mg/dL | Standard Deviation 3.3 |
Primary
Acute Influence of Liver Function, Alanine Aminotransferase (ALT), With the Different Formulations of CBD.
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for alanine aminotransferase (ALT).
Time frame: Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Formulation 088 | Acute Influence of Liver Function, Alanine Aminotransferase (ALT), With the Different Formulations of CBD. | 60 minutes | 26.9 U/L | Standard Deviation 10.8 |
| Formulation 088 | Acute Influence of Liver Function, Alanine Aminotransferase (ALT), With the Different Formulations of CBD. | 0 minutes | 26.1 U/L | Standard Deviation 10.1 |
| Formulation 088 | Acute Influence of Liver Function, Alanine Aminotransferase (ALT), With the Different Formulations of CBD. | 240 minutes | 26.0 U/L | Standard Deviation 11.2 |
| Formulation 126 | Acute Influence of Liver Function, Alanine Aminotransferase (ALT), With the Different Formulations of CBD. | 60 minutes | 27.9 U/L | Standard Deviation 10 |
| Formulation 126 | Acute Influence of Liver Function, Alanine Aminotransferase (ALT), With the Different Formulations of CBD. | 0 minutes | 28 U/L | Standard Deviation 10.9 |
| Formulation 126 | Acute Influence of Liver Function, Alanine Aminotransferase (ALT), With the Different Formulations of CBD. | 240 minutes | 28.6 U/L | Standard Deviation 10.6 |
| Formulation 213 | Acute Influence of Liver Function, Alanine Aminotransferase (ALT), With the Different Formulations of CBD. | 60 minutes | 29.3 U/L | Standard Deviation 8.1 |
| Formulation 213 | Acute Influence of Liver Function, Alanine Aminotransferase (ALT), With the Different Formulations of CBD. | 0 minutes | 27.5 U/L | Standard Deviation 8.4 |
| Formulation 213 | Acute Influence of Liver Function, Alanine Aminotransferase (ALT), With the Different Formulations of CBD. | 240 minutes | 28.2 U/L | Standard Deviation 7.9 |
| Formulation 625 | Acute Influence of Liver Function, Alanine Aminotransferase (ALT), With the Different Formulations of CBD. | 60 minutes | 29.1 U/L | Standard Deviation 9.8 |
| Formulation 625 | Acute Influence of Liver Function, Alanine Aminotransferase (ALT), With the Different Formulations of CBD. | 0 minutes | 29 U/L | Standard Deviation 10.6 |
| Formulation 625 | Acute Influence of Liver Function, Alanine Aminotransferase (ALT), With the Different Formulations of CBD. | 240 minutes | 28.7 U/L | Standard Deviation 10.5 |
| Formulation 725 | Acute Influence of Liver Function, Alanine Aminotransferase (ALT), With the Different Formulations of CBD. | 0 minutes | 30.5 U/L | Standard Deviation 11.2 |
| Formulation 725 | Acute Influence of Liver Function, Alanine Aminotransferase (ALT), With the Different Formulations of CBD. | 60 minutes | 30.4 U/L | Standard Deviation 11 |
| Formulation 725 | Acute Influence of Liver Function, Alanine Aminotransferase (ALT), With the Different Formulations of CBD. | 240 minutes | 30.7 U/L | Standard Deviation 11.5 |
| Formulation 725 | Acute Influence of Liver Function, Alanine Aminotransferase (ALT), With the Different Formulations of CBD. | 0 minutes | 27.7 U/L | Standard Deviation 9.1 |
| Formulation 725 | Acute Influence of Liver Function, Alanine Aminotransferase (ALT), With the Different Formulations of CBD. | 240 minutes | 27.6 U/L | Standard Deviation 9.8 |
| Formulation 725 | Acute Influence of Liver Function, Alanine Aminotransferase (ALT), With the Different Formulations of CBD. | 60 minutes | 27.3 U/L | Standard Deviation 8.7 |
Primary
Acute Influence of Liver Function, Albumin, for Different Formulations of CBD.
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for albumin.
Time frame: Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Formulation 088 | Acute Influence of Liver Function, Albumin, for Different Formulations of CBD. | 60 minutes | 3.6 g/dL | Standard Deviation 0.2 |
| Formulation 088 | Acute Influence of Liver Function, Albumin, for Different Formulations of CBD. | 0 minutes | 3.6 g/dL | Standard Deviation 0.3 |
| Formulation 088 | Acute Influence of Liver Function, Albumin, for Different Formulations of CBD. | 240 minutes | 3.4 g/dL | Standard Deviation 0.3 |
| Formulation 126 | Acute Influence of Liver Function, Albumin, for Different Formulations of CBD. | 60 minutes | 3.8 g/dL | Standard Deviation 0.3 |
| Formulation 126 | Acute Influence of Liver Function, Albumin, for Different Formulations of CBD. | 0 minutes | 3.9 g/dL | Standard Deviation 0.3 |
| Formulation 126 | Acute Influence of Liver Function, Albumin, for Different Formulations of CBD. | 240 minutes | 3.9 g/dL | Standard Deviation 0.3 |
| Formulation 213 | Acute Influence of Liver Function, Albumin, for Different Formulations of CBD. | 60 minutes | 3.8 g/dL | Standard Deviation 0.3 |
| Formulation 213 | Acute Influence of Liver Function, Albumin, for Different Formulations of CBD. | 0 minutes | 3.9 g/dL | Standard Deviation 0.2 |
| Formulation 213 | Acute Influence of Liver Function, Albumin, for Different Formulations of CBD. | 240 minutes | 3.9 g/dL | Standard Deviation 0.3 |
| Formulation 625 | Acute Influence of Liver Function, Albumin, for Different Formulations of CBD. | 60 minutes | 3.8 g/dL | Standard Deviation 0.2 |
| Formulation 625 | Acute Influence of Liver Function, Albumin, for Different Formulations of CBD. | 0 minutes | 3.8 g/dL | Standard Deviation 0.3 |
| Formulation 625 | Acute Influence of Liver Function, Albumin, for Different Formulations of CBD. | 240 minutes | 3.9 g/dL | Standard Deviation 0.2 |
| Formulation 725 | Acute Influence of Liver Function, Albumin, for Different Formulations of CBD. | 60 minutes | 3.8 g/dL | Standard Deviation 0.2 |
| Formulation 725 | Acute Influence of Liver Function, Albumin, for Different Formulations of CBD. | 0 minutes | 3.8 g/dL | Standard Deviation 0.3 |
| Formulation 725 | Acute Influence of Liver Function, Albumin, for Different Formulations of CBD. | 240 minutes | 4.0 g/dL | Standard Deviation 0.2 |
| Formulation 725 | Acute Influence of Liver Function, Albumin, for Different Formulations of CBD. | 0 minutes | 3.8 g/dL | Standard Deviation 0.3 |
| Formulation 725 | Acute Influence of Liver Function, Albumin, for Different Formulations of CBD. | 240 minutes | 3.9 g/dL | Standard Deviation 0.2 |
| Formulation 725 | Acute Influence of Liver Function, Albumin, for Different Formulations of CBD. | 60 minutes | 3.8 g/dL | Standard Deviation 0.2 |
Primary
Acute Influence of Liver Function, Alkaline Phosphatase, With the Different Formulations of CBD.
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for alkaline phosphatase.
Time frame: Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Formulation 088 | Acute Influence of Liver Function, Alkaline Phosphatase, With the Different Formulations of CBD. | 60 minutes | 62.9 U/L | Standard Deviation 9.8 |
| Formulation 088 | Acute Influence of Liver Function, Alkaline Phosphatase, With the Different Formulations of CBD. | 0 minutes | 62.1 U/L | Standard Deviation 8.6 |
| Formulation 088 | Acute Influence of Liver Function, Alkaline Phosphatase, With the Different Formulations of CBD. | 240 minutes | 58.8 U/L | Standard Deviation 8.5 |
| Formulation 126 | Acute Influence of Liver Function, Alkaline Phosphatase, With the Different Formulations of CBD. | 60 minutes | 60.5 U/L | Standard Deviation 7.2 |
| Formulation 126 | Acute Influence of Liver Function, Alkaline Phosphatase, With the Different Formulations of CBD. | 0 minutes | 62.5 U/L | Standard Deviation 7.9 |
| Formulation 126 | Acute Influence of Liver Function, Alkaline Phosphatase, With the Different Formulations of CBD. | 240 minutes | 60.2 U/L | Standard Deviation 8 |
| Formulation 213 | Acute Influence of Liver Function, Alkaline Phosphatase, With the Different Formulations of CBD. | 60 minutes | 61.9 U/L | Standard Deviation 11 |
| Formulation 213 | Acute Influence of Liver Function, Alkaline Phosphatase, With the Different Formulations of CBD. | 0 minutes | 63.6 U/L | Standard Deviation 10.8 |
| Formulation 213 | Acute Influence of Liver Function, Alkaline Phosphatase, With the Different Formulations of CBD. | 240 minutes | 61.4 U/L | Standard Deviation 9.6 |
| Formulation 625 | Acute Influence of Liver Function, Alkaline Phosphatase, With the Different Formulations of CBD. | 60 minutes | 61 U/L | Standard Deviation 8.7 |
| Formulation 625 | Acute Influence of Liver Function, Alkaline Phosphatase, With the Different Formulations of CBD. | 0 minutes | 60.3 U/L | Standard Deviation 6.8 |
| Formulation 625 | Acute Influence of Liver Function, Alkaline Phosphatase, With the Different Formulations of CBD. | 240 minutes | 62.1 U/L | Standard Deviation 9.5 |
| Formulation 725 | Acute Influence of Liver Function, Alkaline Phosphatase, With the Different Formulations of CBD. | 60 minutes | 61.6 U/L | Standard Deviation 9.3 |
| Formulation 725 | Acute Influence of Liver Function, Alkaline Phosphatase, With the Different Formulations of CBD. | 0 minutes | 61.9 U/L | Standard Deviation 9.4 |
| Formulation 725 | Acute Influence of Liver Function, Alkaline Phosphatase, With the Different Formulations of CBD. | 240 minutes | 62.3 U/L | Standard Deviation 9.2 |
| Formulation 725 | Acute Influence of Liver Function, Alkaline Phosphatase, With the Different Formulations of CBD. | 0 minutes | 60.4 U/L | Standard Deviation 12 |
| Formulation 725 | Acute Influence of Liver Function, Alkaline Phosphatase, With the Different Formulations of CBD. | 240 minutes | 61 U/L | Standard Deviation 12.6 |
| Formulation 725 | Acute Influence of Liver Function, Alkaline Phosphatase, With the Different Formulations of CBD. | 60 minutes | 60.9 U/L | Standard Deviation 11.4 |
Primary
Acute Influence of Liver Function, Aspartate Aminotransferase, With the Different Formulations of CBD.
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for aspartate aminotransferase.
Time frame: Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Formulation 088 | Acute Influence of Liver Function, Aspartate Aminotransferase, With the Different Formulations of CBD. | 240 minutes | 29.4 U/L | Standard Deviation 10.1 |
| Formulation 088 | Acute Influence of Liver Function, Aspartate Aminotransferase, With the Different Formulations of CBD. | 60 minutes | 30.7 U/L | Standard Deviation 10.4 |
| Formulation 088 | Acute Influence of Liver Function, Aspartate Aminotransferase, With the Different Formulations of CBD. | 0 minutes | 28.0 U/L | Standard Deviation 12.3 |
| Formulation 126 | Acute Influence of Liver Function, Aspartate Aminotransferase, With the Different Formulations of CBD. | 240 minutes | 31.1 U/L | Standard Deviation 6.8 |
| Formulation 126 | Acute Influence of Liver Function, Aspartate Aminotransferase, With the Different Formulations of CBD. | 0 minutes | 30.5 U/L | Standard Deviation 4.1 |
| Formulation 126 | Acute Influence of Liver Function, Aspartate Aminotransferase, With the Different Formulations of CBD. | 60 minutes | 30.6 U/L | Standard Deviation 4.6 |
| Formulation 213 | Acute Influence of Liver Function, Aspartate Aminotransferase, With the Different Formulations of CBD. | 240 minutes | 30.3 U/L | Standard Deviation 4.1 |
| Formulation 213 | Acute Influence of Liver Function, Aspartate Aminotransferase, With the Different Formulations of CBD. | 60 minutes | 29.4 U/L | Standard Deviation 8.7 |
| Formulation 213 | Acute Influence of Liver Function, Aspartate Aminotransferase, With the Different Formulations of CBD. | 0 minutes | 30.2 U/L | Standard Deviation 3.4 |
| Formulation 625 | Acute Influence of Liver Function, Aspartate Aminotransferase, With the Different Formulations of CBD. | 0 minutes | 33.5 U/L | Standard Deviation 7 |
| Formulation 625 | Acute Influence of Liver Function, Aspartate Aminotransferase, With the Different Formulations of CBD. | 60 minutes | 30.9 U/L | Standard Deviation 5.1 |
| Formulation 625 | Acute Influence of Liver Function, Aspartate Aminotransferase, With the Different Formulations of CBD. | 240 minutes | 30.4 U/L | Standard Deviation 5.9 |
| Formulation 725 | Acute Influence of Liver Function, Aspartate Aminotransferase, With the Different Formulations of CBD. | 0 minutes | 30.6 U/L | Standard Deviation 7.3 |
| Formulation 725 | Acute Influence of Liver Function, Aspartate Aminotransferase, With the Different Formulations of CBD. | 60 minutes | 31.4 U/L | Standard Deviation 7.4 |
| Formulation 725 | Acute Influence of Liver Function, Aspartate Aminotransferase, With the Different Formulations of CBD. | 240 minutes | 31.9 U/L | Standard Deviation 7.5 |
| Formulation 725 | Acute Influence of Liver Function, Aspartate Aminotransferase, With the Different Formulations of CBD. | 0 minutes | 29.2 U/L | Standard Deviation 5 |
| Formulation 725 | Acute Influence of Liver Function, Aspartate Aminotransferase, With the Different Formulations of CBD. | 240 minutes | 29.6 U/L | Standard Deviation 4.4 |
| Formulation 725 | Acute Influence of Liver Function, Aspartate Aminotransferase, With the Different Formulations of CBD. | 60 minutes | 28.9 U/L | Standard Deviation 4.3 |
Primary
Acute Influence of Liver Function, Total Bilirubin, With the Different Formulations of CBD.
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be collected at standardized intervals and analyzed for total bilirubin.
Time frame: Change from baseline at time 0, 60, 240 minutes for each formulation, visits separated by 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Formulation 088 | Acute Influence of Liver Function, Total Bilirubin, With the Different Formulations of CBD. | 60 minutes | 0.8 mg/dL | Standard Deviation 0.3 |
| Formulation 088 | Acute Influence of Liver Function, Total Bilirubin, With the Different Formulations of CBD. | 0 minutes | 0.8 mg/dL | Standard Deviation 0.3 |
| Formulation 088 | Acute Influence of Liver Function, Total Bilirubin, With the Different Formulations of CBD. | 240 minutes | 0.8 mg/dL | Standard Deviation 0.3 |
| Formulation 126 | Acute Influence of Liver Function, Total Bilirubin, With the Different Formulations of CBD. | 0 minutes | 1 mg/dL | Standard Deviation 0.3 |
| Formulation 126 | Acute Influence of Liver Function, Total Bilirubin, With the Different Formulations of CBD. | 60 minutes | 0.9 mg/dL | Standard Deviation 0.2 |
| Formulation 126 | Acute Influence of Liver Function, Total Bilirubin, With the Different Formulations of CBD. | 240 minutes | 1 mg/dL | Standard Deviation 0.3 |
| Formulation 213 | Acute Influence of Liver Function, Total Bilirubin, With the Different Formulations of CBD. | 0 minutes | 1 mg/dL | Standard Deviation 0.6 |
| Formulation 213 | Acute Influence of Liver Function, Total Bilirubin, With the Different Formulations of CBD. | 240 minutes | 1.1 mg/dL | Standard Deviation 0.6 |
| Formulation 213 | Acute Influence of Liver Function, Total Bilirubin, With the Different Formulations of CBD. | 60 minutes | 1 mg/dL | Standard Deviation 0.6 |
| Formulation 625 | Acute Influence of Liver Function, Total Bilirubin, With the Different Formulations of CBD. | 60 minutes | 1 mg/dL | Standard Deviation 0.4 |
| Formulation 625 | Acute Influence of Liver Function, Total Bilirubin, With the Different Formulations of CBD. | 240 minutes | 1.1 mg/dL | Standard Deviation 0.4 |
| Formulation 625 | Acute Influence of Liver Function, Total Bilirubin, With the Different Formulations of CBD. | 0 minutes | 1 mg/dL | Standard Deviation 0.4 |
| Formulation 725 | Acute Influence of Liver Function, Total Bilirubin, With the Different Formulations of CBD. | 0 minutes | .9 mg/dL | Standard Deviation 0.2 |
| Formulation 725 | Acute Influence of Liver Function, Total Bilirubin, With the Different Formulations of CBD. | 60 minutes | 0.9 mg/dL | Standard Deviation 0.2 |
| Formulation 725 | Acute Influence of Liver Function, Total Bilirubin, With the Different Formulations of CBD. | 240 minutes | 1 mg/dL | Standard Deviation 0.3 |
| Formulation 725 | Acute Influence of Liver Function, Total Bilirubin, With the Different Formulations of CBD. | 240 minutes | 1 mg/dL | Standard Deviation 0.4 |
| Formulation 725 | Acute Influence of Liver Function, Total Bilirubin, With the Different Formulations of CBD. | 0 minutes | .9 mg/dL | Standard Deviation 0.4 |
| Formulation 725 | Acute Influence of Liver Function, Total Bilirubin, With the Different Formulations of CBD. | 60 minutes | 0.9 mg/dL | Standard Deviation 0.4 |
Primary
CBD on Postprandial Metabolism Via Indirect Calorimetry
At the 2 randomized visits including a Resting Metabolic Rate prior to and after ingestion of a single dose of Formulation 725 or placebo.
Time frame: Compare 2 randomized visits Including a test meal collected during 45 minutes of resting metabolic rate
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Formulation 088 | CBD on Postprandial Metabolism Via Indirect Calorimetry | 1751.7 kcal/day | Standard Deviation 271.96 |
| Formulation 126 | CBD on Postprandial Metabolism Via Indirect Calorimetry | 1755.31 kcal/day | Standard Deviation 289.97 |
Primary
CBD Pharmacokinetic Volume of Distribution- (Vd) for Different Formulations of CBD
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Vd (L).
Time frame: Venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
Population: Data not collected or analyzed in groups listing 0 for overall number of participants analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Formulation 126 | CBD Pharmacokinetic Volume of Distribution- (Vd) for Different Formulations of CBD | 11836405 mL, 1 L is equal to 1,000 mL | Standard Error 7642484 |
| Formulation 213 | CBD Pharmacokinetic Volume of Distribution- (Vd) for Different Formulations of CBD | 13130100 mL, 1 L is equal to 1,000 mL | Standard Error 6339554 |
| Formulation 725 | CBD Pharmacokinetic Volume of Distribution- (Vd) for Different Formulations of CBD | 22687960 mL, 1 L is equal to 1,000 mL | Standard Error 16435999 |
Primary
Ingested CBD on Postprandial Metabolism Via Indirect Calorimetry
At the 2 randomized visits Including a Test Meal Thermic Effect of Feeding (TEF) Under the Curve was calculated from standardized intervals prior to and after ingestion of a liquid meal and a single dose of Formulation 725.
Time frame: Randomized visit Including a test meal collected during 235 minutes of TEF
Population: The thermic effect of feeding refers to the increase in energy expenditure after eating. On the X-axis, the independent variable is time, and the unit is minutes (min). On the Y-axis, the dependent variable is energy expenditure, and the unit is kilocalories per minute (kcal/min). Thus, the unit for area under the curve is kcal/min X min.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Formulation 088 | Ingested CBD on Postprandial Metabolism Via Indirect Calorimetry | 58.83 (kcal/min) x min | Standard Deviation 14.3 |
| Formulation 126 | Ingested CBD on Postprandial Metabolism Via Indirect Calorimetry | 55.28 (kcal/min) x min | Standard Deviation 27.62 |
Primary
Ingested CBD on Postprandial Metabolism Via Measurements of Glucose
At the 2 randomized visits Including a Test Meal, glucose Area Under the Curve was calculated from standardized intervals after ingestion of a liquid meal and a single dose of Formulation 725.
Time frame: Compare 2 randomized visits Including a test meal collected at baseline,10,20,30,45,60,90,120,150,180,210, and 240 minutes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Formulation 088 | Ingested CBD on Postprandial Metabolism Via Measurements of Glucose | 18634.8 min x mg/dL | Standard Deviation 2651.8 |
| Formulation 126 | Ingested CBD on Postprandial Metabolism Via Measurements of Glucose | 19001.72 min x mg/dL | Standard Deviation 4037.1 |
Primary
Ingested CBD on Postprandial Metabolism Via Measurements of Insulin
At the 2 randomized visits Including a Test Meal insulin Area Under the Curve was calculated from standardized intervals after ingestion of a liquid meal and a single dose of Formulation 725.
Time frame: Compare 2 randomized visits Including a test meal collected at baseline,10,20,30,45,60,90,120,150,180,210, and 240 minutes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Formulation 088 | Ingested CBD on Postprandial Metabolism Via Measurements of Insulin | 7043.3 min x mU/L | Standard Deviation 4780.8 |
| Formulation 126 | Ingested CBD on Postprandial Metabolism Via Measurements of Insulin | 6934.75 min x mU/L | Standard Deviation 4556.64 |
Primary
Ingested CBD on Postprandial Metabolism Via Measurements of Triglycerides
At the 2 randomized visits Including a Test Meal triglyceride Area Under the Curve was calculated from standardized intervals after ingestion of a liquid meal and a single dose of Formulation 725.
Time frame: Compare 2 randomized visits Including a test meal collected at baseline,10,20,30,45,60,90,120,150,180,210, and 240 minutes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Formulation 088 | Ingested CBD on Postprandial Metabolism Via Measurements of Triglycerides | 24978.8 min x mg/dL | Standard Deviation 9538.7 |
| Formulation 126 | Ingested CBD on Postprandial Metabolism Via Measurements of Triglycerides | 30605.36 min x mg/dL | Standard Deviation 17037.6 |
Primary
Pharmacokinetic Amount of Time it Takes to Decrease the Circulating Concentration to Half of Its Initial Value (t1/2) for Different Formulations of CBD
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate t1/2 (mins).
Time frame: venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Formulation 088 | Pharmacokinetic Amount of Time it Takes to Decrease the Circulating Concentration to Half of Its Initial Value (t1/2) for Different Formulations of CBD | 280.7 minutes | Standard Deviation 141.5 |
| Formulation 126 | Pharmacokinetic Amount of Time it Takes to Decrease the Circulating Concentration to Half of Its Initial Value (t1/2) for Different Formulations of CBD | 171.0 minutes | Standard Deviation 129.2 |
| Formulation 213 | Pharmacokinetic Amount of Time it Takes to Decrease the Circulating Concentration to Half of Its Initial Value (t1/2) for Different Formulations of CBD | 140.5 minutes | Standard Deviation 96.6 |
| Formulation 625 | Pharmacokinetic Amount of Time it Takes to Decrease the Circulating Concentration to Half of Its Initial Value (t1/2) for Different Formulations of CBD | 442.7 minutes | Standard Deviation 451 |
| Formulation 725 | Pharmacokinetic Amount of Time it Takes to Decrease the Circulating Concentration to Half of Its Initial Value (t1/2) for Different Formulations of CBD | 133.1 minutes | Standard Deviation 26.7 |
Primary
Pharmacokinetic Area Under the Curve an Estimate of Total Exposure to CBD Over Time (AUC 0-inf) for Different Formulations of CBD
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate AUC 0-inf (mins x ng/mL).
Time frame: Venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
Population: Data not collected or analyzed in groups listing 0 for overall number of participants analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Formulation 126 | Pharmacokinetic Area Under the Curve an Estimate of Total Exposure to CBD Over Time (AUC 0-inf) for Different Formulations of CBD | 385.2 minutes x ng/mL | Standard Deviation 226.6 |
| Formulation 213 | Pharmacokinetic Area Under the Curve an Estimate of Total Exposure to CBD Over Time (AUC 0-inf) for Different Formulations of CBD | 367.6 minutes x ng/mL | Standard Deviation 217.1 |
| Formulation 725 | Pharmacokinetic Area Under the Curve an Estimate of Total Exposure to CBD Over Time (AUC 0-inf) for Different Formulations of CBD | 301.6 minutes x ng/mL | Standard Deviation 221.9 |
Primary
Pharmacokinetic Area Under the Curve Representing Total Cannabidiol Exposure Between 0 and 4 h (AUC 0-4) for Different Formulations of CBD
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate AUC 0-4 (min x ng/mL).
Time frame: Venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Formulation 088 | Pharmacokinetic Area Under the Curve Representing Total Cannabidiol Exposure Between 0 and 4 h (AUC 0-4) for Different Formulations of CBD | 62.8 minutes x ng/mL | Standard Deviation 29.7 |
| Formulation 126 | Pharmacokinetic Area Under the Curve Representing Total Cannabidiol Exposure Between 0 and 4 h (AUC 0-4) for Different Formulations of CBD | 272.3 minutes x ng/mL | Standard Deviation 176 |
| Formulation 213 | Pharmacokinetic Area Under the Curve Representing Total Cannabidiol Exposure Between 0 and 4 h (AUC 0-4) for Different Formulations of CBD | 208.6 minutes x ng/mL | Standard Deviation 151.1 |
| Formulation 625 | Pharmacokinetic Area Under the Curve Representing Total Cannabidiol Exposure Between 0 and 4 h (AUC 0-4) for Different Formulations of CBD | 46 minutes x ng/mL | Standard Deviation 59.4 |
| Formulation 725 | Pharmacokinetic Area Under the Curve Representing Total Cannabidiol Exposure Between 0 and 4 h (AUC 0-4) for Different Formulations of CBD | 177.3 minutes x ng/mL | Standard Deviation 104.8 |
Primary
Pharmacokinetic Maximum Concentration-(Cmax) for Different Formulations of CBD
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Cmax (ng/mL).
Time frame: venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Formulation 088 | Pharmacokinetic Maximum Concentration-(Cmax) for Different Formulations of CBD | 0.5 ng/mL | Standard Deviation 0.2 |
| Formulation 126 | Pharmacokinetic Maximum Concentration-(Cmax) for Different Formulations of CBD | 3.1 ng/mL | Standard Deviation 2.1 |
| Formulation 213 | Pharmacokinetic Maximum Concentration-(Cmax) for Different Formulations of CBD | 2.2 ng/mL | Standard Deviation 2 |
| Formulation 625 | Pharmacokinetic Maximum Concentration-(Cmax) for Different Formulations of CBD | 0.4 ng/mL | Standard Deviation 0.6 |
| Formulation 725 | Pharmacokinetic Maximum Concentration-(Cmax) for Different Formulations of CBD | 1.8 ng/mL | Standard Deviation 1.5 |
Primary
Pharmacokinetic Parameter AUC 0-4 of Formulation 725 After a Standardized Meal
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD AUC 0-4 (min x ng/mL).
Time frame: venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Formulation 088 | Pharmacokinetic Parameter AUC 0-4 of Formulation 725 After a Standardized Meal | 397 min x ng/mL | Standard Deviation 167 |
Primary
Pharmacokinetic Parameter AUC 0-inf of Formulation 725 After a Standardized Meal
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD AUC 0-inf (min x ng/mL).
Time frame: venous blood will be sampled at standardized intervals 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
Population: Data not Collected
Primary
Pharmacokinetic Parameter Cmax of a Formulation 725 After a Standardized Meal
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Cmax (ng/L).
Time frame: venous blood will be sampled at standardized intervals over: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Formulation 088 | Pharmacokinetic Parameter Cmax of a Formulation 725 After a Standardized Meal | 2.9 ng/mL. 1 L is equal to 1,000 mL. | Standard Deviation 1.3 |
Primary
Pharmacokinetic Parameter Ka of Formulation 725 After a Standardized Meal
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Ka (1/h).
Time frame: venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
Population: Data not collected
Primary
Pharmacokinetic Parameter Ke of Formulation 725 After a Standardized Meal
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Ke (1/h).
Time frame: venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Formulation 088 | Pharmacokinetic Parameter Ke of Formulation 725 After a Standardized Meal | 0.005 1/hour | Standard Deviation 0.002 |
Primary
Pharmacokinetic Parameter t1/2 of Formulation 725 After a Standardized Meal
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD t1/2 (h).
Time frame: venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Formulation 088 | Pharmacokinetic Parameter t1/2 of Formulation 725 After a Standardized Meal | 248.6 minutes, 1 hour is equal to 60 minutes. | Standard Deviation 304.6 |
Primary
Pharmacokinetic Parameter Tmax of a Formulation 725 After a Standardized Meal
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts the time to attain peak circulating concentration Tmax (mins).
Time frame: venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Formulation 088 | Pharmacokinetic Parameter Tmax of a Formulation 725 After a Standardized Meal | 113.6 minutes | Standard Deviation 70.5 |
Primary
Pharmacokinetic Parameter Vd of Formulation 725 After a Standardized Meal
At the 2 randomized visits Including a Test Meal, determine if a high-fat meal impacts maximal concentration of circulating CBD Vd (L).
Time frame: venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
Population: Data Not Collected
Primary
Pharmacokinetic Rate at Which CBD is Absorbed Into the Body (Ka) for Different Formulations of CBD
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Ka(1/h).
Time frame: venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
Population: Outcome measure not collected
Primary
Pharmacokinetic Rate at Which CBD is Removed From the Body (Ke) for Different Formulations of CBD
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Ke (1/h).
Time frame: venous blood will be sampled at standardized intervals over 4-hours: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Formulation 088 | Pharmacokinetic Rate at Which CBD is Removed From the Body (Ke) for Different Formulations of CBD | 00.003 1/h | Standard Deviation 0.001 |
| Formulation 126 | Pharmacokinetic Rate at Which CBD is Removed From the Body (Ke) for Different Formulations of CBD | .006 1/h | Standard Deviation 0.003 |
| Formulation 213 | Pharmacokinetic Rate at Which CBD is Removed From the Body (Ke) for Different Formulations of CBD | .006 1/h | Standard Deviation 0.002 |
| Formulation 625 | Pharmacokinetic Rate at Which CBD is Removed From the Body (Ke) for Different Formulations of CBD | 0.003 1/h | Standard Deviation 0.002 |
| Formulation 725 | Pharmacokinetic Rate at Which CBD is Removed From the Body (Ke) for Different Formulations of CBD | 0.005 1/h | Standard Deviation 0.001 |
Primary
Pharmacokinetic Time to Maximum Concentration- (Tmax) for Different Formulations of CBD
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Tmax (minutes).
Time frame: Venous blood will be sampled at standardized intervals: 0, 10, 20, 30, 45, 60, 120, 180, and 240 minutes and will be analyzed to compare circulating CBD concentration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Formulation 088 | Pharmacokinetic Time to Maximum Concentration- (Tmax) for Different Formulations of CBD | 116.3 minutes | Standard Deviation 76 |
| Formulation 126 | Pharmacokinetic Time to Maximum Concentration- (Tmax) for Different Formulations of CBD | 35.4 minutes | Standard Deviation 13.5 |
| Formulation 213 | Pharmacokinetic Time to Maximum Concentration- (Tmax) for Different Formulations of CBD | 51.8 minutes | Standard Deviation 24.2 |
| Formulation 625 | Pharmacokinetic Time to Maximum Concentration- (Tmax) for Different Formulations of CBD | 129.5 minutes | Standard Deviation 89.6 |
| Formulation 725 | Pharmacokinetic Time to Maximum Concentration- (Tmax) for Different Formulations of CBD | 38.2 minutes | Standard Deviation 24.9 |