Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Compare different formulations of CBD Pharmacokinetic Time to Maximum Concentration- (Tmax) |
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 (hours). |
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. |
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Primary |
Compare different formulations of CBD Pharmacokinetic maximum concentration-(Cmax). |
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). |
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. |
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Primary |
Compare different formulations of CBD Pharmacokinetic area under the curve representing total cannabidiol exposure between 0 and 4 h (AUC 0-4) |
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 (h x ng/mL). |
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. |
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Primary |
Compare different formulations of CBD Pharmacokinetic area under the curve an estimate of total exposure to CBD over time (AUC 0-inf). |
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 (h x ng/mL). |
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. |
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Primary |
Compare different formulations of CBD Pharmacokinetic amount of time it takes to decrease the circulating concentration to half of its initial value (t1/2). |
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 (h). |
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. |
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Primary |
Compare different formulations of CBD Pharmacokinetic rate at which CBD is absorbed into the body (Ka). |
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). |
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. |
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Primary |
Compare different formulations of CBD Pharmacokinetic rate at which CBD is removed from the body (Ke). |
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). |
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. |
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Primary |
Compare different formulations of CBD Pharmacokinetic volume of distribution- (Vd) |
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). |
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. |
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Primary |
Determine the Pharmacokinetic parameter Tmax of a T-P-S-10 Caliper powder - 30 mg CBD in the form of 300 mg of 10% CBD isolate after 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 (h). |
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. |
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Primary |
Determine the Pharmacokinetic parameter Cmax of a T-P-S-10 Caliper powder - 30 mg CBD in the form of 300 mg of 10% CBD isolate after 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). |
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. |
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Primary |
Determine the Pharmacokinetic parameter AUC 0-4 of a T-P-S-10 Caliper powder - 30 mg CBD in the form of 300 mg of 10% CBD isolate after 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 (hxng/mL). |
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. |
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Primary |
Determine the Pharmacokinetic parameter AUC 0-inf of a T-P-S-10 Caliper powder - 30 mg CBD in the form of 300 mg of 10% CBD isolate after 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 (hxng/mL). |
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. |
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Primary |
Determine the Pharmacokinetic parameter t1/2 of a T-P-S-10 Caliper powder - 30 mg CBD in the form of 300 mg of 10% CBD isolate after 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). |
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. |
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Primary |
Determine the Pharmacokinetic parameter Ka of a T-P-S-10 Caliper powder - 30 mg CBD in the form of 300 mg of 10% CBD isolate after 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). |
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. |
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Primary |
Determine the Pharmacokinetic parameter Ke of a T-P-S-10 Caliper powder - 30 mg CBD in the form of 300 mg of 10% CBD isolate after 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). |
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. |
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Primary |
Determine the Pharmacokinetic parameter Vd of a T-P-S-10 Caliper powder - 30 mg CBD in the form of 300 mg of 10% CBD isolate after 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). |
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. |
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Primary |
Determine ingested CBD on postprandial metabolism via indirect calorimetry |
At the 2 randomized visits Including a Test Meal measure resting metabolic rate (RMR- kcal/day) followed immediately by ingestion of a liquid meal and a single 30 mg dose of Caliper powder - 30 mg CBD in the form of 300 mg of 10% CBD isolate or a placebo. |
Change from the 2 randomized visits Including a test meal separated by 4 days |
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Primary |
Determine ingested CBD on postprandial metabolism via measurements of glucose |
At the 2 randomized visits Including a Test Meal measure blood glucose at standardized intervals after ingestion of a liquid meal and a single dose of Caliper powder - 30 mg CBD in the form of 300 mg of 10% CBD isolate or a placebo. |
Compare 2 randomized visits Including a test meal collected at 90,150,210,725 minutes. |
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Primary |
Determine ingested CBD on postprandial metabolism via measurements of insulin |
At the 2 randomized visits Including a Test Meal measure insulin at standardized intervals after ingestion of a liquid meal and a single dose of Caliper powder - 30 mg CBD in the form of 300 mg of 10% CBD isolate or a placebo. |
Compare 2 randomized visits Including a test meal collected at 90,150,210,725 minutes. |
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Primary |
Determine ingested CBD on postprandial metabolism via measurements of triglycerides |
At the 2 randomized visits Including a Test Meal measure triglycerides at standardized intervals after ingestion of a liquid meal and a single dose of Caliper powder - 30 mg CBD in the form of 300 mg of 10% CBD isolate or a placebo. |
Compare 2 randomized visits Including a test meal collected at 90,150,210,725 minutes. |
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Primary |
Determine the change in the 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). |
Change from baseline at time 0, 60, 120 minutes for each formulation, visits separated by 14 days |
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Primary |
Determine the change in the acute influence of liver function, albumin, 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 albumin. |
Change from baseline at time 0, 60, 120 minutes for each formulation, visits separated by 14 days |
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Primary |
Determine the change in the 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. |
Change from baseline at time 0, 60, 120 minutes for each formulation, visits separated by 14 days |
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Primary |
Determine the change in the 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. |
Change from baseline at time 0, 60, 120 minutes for each formulation, visits separated by 14 days |
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Primary |
Determine the change in the 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. |
Change from baseline at time 0, 60, 120 minutes for each formulation, visits separated by 14 days |
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Primary |
Determine the change in the 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. |
Change from baseline at time 0, 60, 120 minutes for each formulation, visits separated by 14 days |
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