Trial · NCT05032807

Pharmacokinetic Study of a Novel Lipid Formulation of Cannabidiol Compared to a Standard Formulation

NCT05032807, Phase 1, Completed, King's College London; results first posted 2024-02-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pharmacokinetic Study of a Novel Lipid Formulation of Cannabidiol Compared to a Standard Formulation. Trials, record NCT05032807. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05032807

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Pharmacokinetic Study of a Novel Lipid Formulation of Cannabidiol Compared to a Standard Formulation
NCT number: NCT05032807
Status: Completed
Phases: Phase 1
Enrollment: 14 participants, actual
Lead sponsor: King's College London
Conditions: Absorption; Chemicals
Interventions: Standard formulation, Novel formulation
First posted: 2021-09-02
Last updated: 2024-02-06
Results first posted: 2024-02-06
Limitations and caveats: Halflife and AUCinf could not be calculated for all participants in the standard CBD arm as plasma levels were not falling at the final time point.

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Total Drug Exposure. (Area Under the Curve to Infinity [AUC(Inf)]	0 - 48 hours	Difference in AUC(inf) for a single dose of oral CBD between the novel and standard formulations in the fasting state.
Secondary	Cmax	0 - 48 hours	Maximum plasma concentration
Secondary	Tmax	0 - 48 hours	Time after administration of drug when maximum plasma concentration is reached
Secondary	Plasma Half-life (t½)	0 - 48 hours	Half-life
Secondary	48 Hour Drug Exposure (AUC0-48)	0 - 48 hours	Area under the concentration-time curve from time zero to 48hours
Secondary	Gastrointestinal Symptom Rating Scale (GSRS) - Total Score	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).

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Total Drug Exposure. (Area Under the Curve to Infinity [AUC(Inf)]	0 - 48 hours	AUCinf could not be calculated for three participants in the standard CBD arm as plasma levels were not falling at the final time point.	ng*h/ml	GEOMETRIC_MEAN
SECONDARY	Cmax	0 - 48 hours		ng/ml	GEOMETRIC_MEAN
SECONDARY	Tmax	0 - 48 hours		hours	MEDIAN
SECONDARY	Plasma Half-life (t½)	0 - 48 hours		hours	MEAN
SECONDARY	48 Hour Drug Exposure (AUC0-48)	0 - 48 hours		ng*h/ml	GEOMETRIC_MEAN
SECONDARY	Gastrointestinal Symptom Rating Scale (GSRS) - Total Score	The scale will be used pre-dose and at 24 and 48 hours post dose.		Mean score	MEAN

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Total Drug Exposure. (Area Under the Curve to Infinity [AUC(Inf)]	Novel Lipid Formulation Cannabidiol	674.9	Geometric Coefficient of Variation 103.05	ng*h/ml
Total Drug Exposure. (Area Under the Curve to Infinity [AUC(Inf)]	Standard Formulation Cannabidiol	134.76	Geometric Coefficient of Variation 88.70	ng*h/ml
Cmax	Novel Lipid Formulation Cannabidiol	73.00	Geometric Coefficient of Variation 149.82	ng/ml
Cmax	Standard Formulation Cannabidiol	3.11	Geometric Coefficient of Variation 103.55	ng/ml
Tmax	Novel Lipid Formulation Cannabidiol	4	Full Range 2 to 8	hours
Tmax	Standard Formulation Cannabidiol	6	Full Range 3 to 48	hours
Plasma Half-life (t½)	Novel Lipid Formulation Cannabidiol	13.71	Standard Deviation 5.89	hours
Plasma Half-life (t½)	Standard Formulation Cannabidiol	51.83	Standard Deviation 57.61	hours
48 Hour Drug Exposure (AUC0-48)	Novel Lipid Formulation Cannabidiol	611.42	Geometric Coefficient of Variation 104.60	ng*h/ml
48 Hour Drug Exposure (AUC0-48)	Standard Formulation Cannabidiol	66.79	Geometric Coefficient of Variation 50.65	ng*h/ml

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment 1	STARTED	Novel Lipid Formulation Cannabidiol, Then Standard Formulation Cannabidiol	7
Treatment 1	STARTED	Standard Formulation Cannabidiol, Then Novel Lipid Formulation Cannabidiol	7
Treatment 1	COMPLETED	Novel Lipid Formulation Cannabidiol, Then Standard Formulation Cannabidiol	7
Treatment 1	COMPLETED	Standard Formulation Cannabidiol, Then Novel Lipid Formulation Cannabidiol	7
Treatment 1	NOT COMPLETED	Novel Lipid Formulation Cannabidiol, Then Standard Formulation Cannabidiol	0
Treatment 1	NOT COMPLETED	Standard Formulation Cannabidiol, Then Novel Lipid Formulation Cannabidiol	0
Treatment 2	STARTED	Novel Lipid Formulation Cannabidiol, Then Standard Formulation Cannabidiol	7
Treatment 2	STARTED	Standard Formulation Cannabidiol, Then Novel Lipid Formulation Cannabidiol	7
Treatment 2	COMPLETED	Novel Lipid Formulation Cannabidiol, Then Standard Formulation Cannabidiol	7
Treatment 2	COMPLETED	Standard Formulation Cannabidiol, Then Novel Lipid Formulation Cannabidiol	7

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anxiety	Psychiatric disorders	Novel Lipid Formulation Cannabidiol	1	14
other	Anxiety	Psychiatric disorders	Standard Formulation Cannabidiol	0	14
other	Somnolence	Psychiatric disorders	Novel Lipid Formulation Cannabidiol	7	14
other	Somnolence	Psychiatric disorders	Standard Formulation Cannabidiol	2	14
other	Dizziness	Nervous system disorders	Novel Lipid Formulation Cannabidiol	1	14
other	Dizziness	Nervous system disorders	Standard Formulation Cannabidiol	1	14
other	Nausea	Gastrointestinal disorders	Novel Lipid Formulation Cannabidiol	1	14
other	Nausea	Gastrointestinal disorders	Standard Formulation Cannabidiol	1	14
other	Abdominal pain	Gastrointestinal disorders	Novel Lipid Formulation Cannabidiol	1	14
other	Abdominal pain	Gastrointestinal disorders	Standard Formulation Cannabidiol	0	14

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Novel Lipid Formulation Cannabidiol	0	14
Total, all-cause mortality	Standard Formulation Cannabidiol	0	14
Total, other adverse events	Novel Lipid Formulation Cannabidiol	11	14
Total, other adverse events	Standard Formulation Cannabidiol	8	14
Total, serious adverse events	Novel Lipid Formulation Cannabidiol	0	14
Total, serious adverse events	Standard Formulation Cannabidiol	0	14

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39771516	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Novel Lipid Formulation Cannabidiol vs Standard Formulation Cannabidiol: deaths from any cause	Trial comparisons
Novel Lipid Formulation Cannabidiol vs Standard Formulation Cannabidiol: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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