Trial Outcomes & Findings for Pharmacokinetic Study of a Novel Lipid Formulation of Cannabidiol Compared to a Standard Formulation (NCT NCT05032807)
NCT ID: NCT05032807
Last Updated: 2024-02-06
Results Overview
Difference in AUC(inf) for a single dose of oral CBD between the novel and standard formulations in the fasting state.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
0 - 48 hours
Results posted on
2024-02-06
Participant Flow
Participant milestones
| Measure |
Novel Lipid Formulation Cannabidiol, Then Standard Formulation Cannabidiol
Cannabidiol novel formulation: Cannabidiol 1000mg with lipid matrix, single dose, oral
Cannabidiol standard formulation: Cannabidiol 1000mg, single dose, oral
|
Standard Formulation Cannabidiol, Then Novel Lipid Formulation Cannabidiol
Cannabidiol standard formulation: Cannabidiol 1000mg, single dose, oral
Cannabidiol novel formulation: Cannabidiol 1000mg with lipid matrix, single dose, oral
|
|---|---|---|
|
Treatment 1
STARTED
|
7
|
7
|
|
Treatment 1
COMPLETED
|
7
|
7
|
|
Treatment 1
NOT COMPLETED
|
0
|
0
|
|
Treatment 2
STARTED
|
7
|
7
|
|
Treatment 2
COMPLETED
|
7
|
7
|
|
Treatment 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic Study of a Novel Lipid Formulation of Cannabidiol Compared to a Standard Formulation
Baseline characteristics by cohort
| Measure |
Novel Lipid Formulation Then Standard Formulation
n=7 Participants
Period 1: Cannabidiol 1000mg with lipid matrix, single dose, oral
Period 2: Cannabidiol standard formulation: Cannabidiol 1000mg standard formulation, single dose, oral
|
Standard Formulation Then Novel Lipid Formulation
n=7 Participants
Period 1: Cannabidiol standard formulation: Cannabidiol 1000mg standard formulation, single dose, oral
Period 2: Cannabidiol novel formulation: Cannabidiol 1000mg with lipid matrix, single dose, oral
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
26.7 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
26.7 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
26.7 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 - 48 hoursPopulation: AUCinf could not be calculated for three participants in the standard CBD arm as plasma levels were not falling at the final time point.
Difference in AUC(inf) for a single dose of oral CBD between the novel and standard formulations in the fasting state.
Outcome measures
| Measure |
Novel Lipid Formulation Cannabidiol
n=14 Participants
Cannabidiol novel formulation: Cannabidiol 1000mg with lipid matrix, single dose, oral
|
Standard Formulation Cannabidiol
n=11 Participants
Cannabidiol standard formulation: Cannabidiol 1000mg standard formulation, single dose, oral
|
|---|---|---|
|
Total Drug Exposure. (Area Under the Curve to Infinity [AUC(Inf)]
|
674.9 ng*h/ml
Geometric Coefficient of Variation 103.05
|
134.76 ng*h/ml
Geometric Coefficient of Variation 88.70
|
SECONDARY outcome
Timeframe: 0 - 48 hoursMaximum plasma concentration
Outcome measures
| Measure |
Novel Lipid Formulation Cannabidiol
n=14 Participants
Cannabidiol novel formulation: Cannabidiol 1000mg with lipid matrix, single dose, oral
|
Standard Formulation Cannabidiol
n=14 Participants
Cannabidiol standard formulation: Cannabidiol 1000mg standard formulation, single dose, oral
|
|---|---|---|
|
Cmax
|
73.00 ng/ml
Geometric Coefficient of Variation 149.82
|
3.11 ng/ml
Geometric Coefficient of Variation 103.55
|
SECONDARY outcome
Timeframe: 0 - 48 hoursTime after administration of drug when maximum plasma concentration is reached
Outcome measures
| Measure |
Novel Lipid Formulation Cannabidiol
n=14 Participants
Cannabidiol novel formulation: Cannabidiol 1000mg with lipid matrix, single dose, oral
|
Standard Formulation Cannabidiol
n=14 Participants
Cannabidiol standard formulation: Cannabidiol 1000mg standard formulation, single dose, oral
|
|---|---|---|
|
Tmax
|
4 hours
Interval 2.0 to 8.0
|
6 hours
Interval 3.0 to 48.0
|
SECONDARY outcome
Timeframe: 0 - 48 hoursHalf-life
Outcome measures
| Measure |
Novel Lipid Formulation Cannabidiol
n=14 Participants
Cannabidiol novel formulation: Cannabidiol 1000mg with lipid matrix, single dose, oral
|
Standard Formulation Cannabidiol
n=11 Participants
Cannabidiol standard formulation: Cannabidiol 1000mg standard formulation, single dose, oral
|
|---|---|---|
|
Plasma Half-life (t½)
|
13.71 hours
Standard Deviation 5.89
|
51.83 hours
Standard Deviation 57.61
|
SECONDARY outcome
Timeframe: 0 - 48 hoursArea under the concentration-time curve from time zero to 48hours
Outcome measures
| Measure |
Novel Lipid Formulation Cannabidiol
n=14 Participants
Cannabidiol novel formulation: Cannabidiol 1000mg with lipid matrix, single dose, oral
|
Standard Formulation Cannabidiol
n=14 Participants
Cannabidiol standard formulation: Cannabidiol 1000mg standard formulation, single dose, oral
|
|---|---|---|
|
48 Hour Drug Exposure (AUC0-48)
|
611.42 ng*h/ml
Geometric Coefficient of Variation 104.60
|
66.79 ng*h/ml
Geometric Coefficient of Variation 50.65
|
SECONDARY outcome
Timeframe: The scale will be used pre-dose and at 24 and 48 hours post dose.The GSRS was used to assess gastrointestinal symptoms over the past 24 hours only. It is a 15-item rating scale, where each item is assessed with a 7-point Likert scale, scored from 1 to 7, and with higher scores indicating more severe symptoms. The total score is the mean score across items (minimum score=1; maximum sore=7).
Outcome measures
| Measure |
Novel Lipid Formulation Cannabidiol
n=14 Participants
Cannabidiol novel formulation: Cannabidiol 1000mg with lipid matrix, single dose, oral
|
Standard Formulation Cannabidiol
n=14 Participants
Cannabidiol standard formulation: Cannabidiol 1000mg standard formulation, single dose, oral
|
|---|---|---|
|
Gastrointestinal Symptom Rating Scale (GSRS) - Total Score
Baseline/pre-dose
|
1.09 Mean score
Standard Deviation 0.17
|
1.06 Mean score
Standard Deviation 0.09
|
|
Gastrointestinal Symptom Rating Scale (GSRS) - Total Score
24 hours post dose
|
1.25 Mean score
Standard Deviation 0.36
|
1.06 Mean score
Standard Deviation 0.11
|
|
Gastrointestinal Symptom Rating Scale (GSRS) - Total Score
48 hours post dose
|
1.09 Mean score
Standard Deviation 0.18
|
1.02 Mean score
Standard Deviation 0.04
|
Adverse Events
Novel Lipid Formulation Cannabidiol
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Standard Formulation Cannabidiol
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Novel Lipid Formulation Cannabidiol
n=14 participants at risk
Cannabidiol novel formulation: Cannabidiol 1000mg with lipid matrix, single dose, oral
|
Standard Formulation Cannabidiol
n=14 participants at risk
Cannabidiol standard formulation: Cannabidiol 1000mg standard formulation, single dose, oral
|
|---|---|---|
|
Psychiatric disorders
Anxiety
|
7.1%
1/14 • 14 days
|
0.00%
0/14 • 14 days
|
|
Psychiatric disorders
Somnolence
|
50.0%
7/14 • 14 days
|
14.3%
2/14 • 14 days
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • 14 days
|
7.1%
1/14 • 14 days
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • 14 days
|
7.1%
1/14 • 14 days
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • 14 days
|
0.00%
0/14 • 14 days
|
|
Gastrointestinal disorders
Abdominal distension
|
7.1%
1/14 • 14 days
|
0.00%
0/14 • 14 days
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
2/14 • 14 days
|
0.00%
0/14 • 14 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14 • 14 days
|
7.1%
1/14 • 14 days
|
|
Gastrointestinal disorders
Flatulence
|
7.1%
1/14 • 14 days
|
7.1%
1/14 • 14 days
|
|
General disorders
Other
|
21.4%
3/14 • 14 days
|
42.9%
6/14 • 14 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place