A randomized, double-blind, placebo-controlled, single ascending dose and multiple dose study to evaluate the safety, tolerability and pharmacokinetics of Cannabidiol (GWP42003-P) oral liquid formulation with an open label two-period cross-over part to study food effects in healthy subjects

A randomized, double-blind, placebo-controlled, single ascending dose and multiple dose study to evaluate the safety, tolerability and pharmacokinetics of Cannabidiol (GWP42003-P) oral liquid formulation with an open label two-period cross-over part to study food effects in healthy subjects - Cannabidiol (GWP42003-P) SAD, FE and MD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42686

Enrollment

Registered

2015-05-20

Start date

2015-05-27

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Interventions

The SAD part of the study will consist of 1 study period during which you will receive either CBD or placebo once. CBD and placebo will be given in the form of an oral solution The FE part of the

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - healthy male/ female subjects - 18-45 yrs, inclusive - BMI: 18.0-28.0 kg/m2, inclusive

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood (for men) / 1.0 liters of blood (for women) in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and tolerability of single ascending and multiple doses of cannabidiol (CBD, GWP42003-P) in healthy male and female subjects compared with placebo with respect to: - incidence, type and severity of adverse events (AEs). - vital signs. - 12-lead electrocardiogram (ECG). - clinical laboratory parameters. - physical examination.	—

Secondary

Measure	Time frame
To assess the pharmacokinetics (PK) of single ascending and multiple doses of CBD (GWP42003-P) in healthy male and female subjects. To assess the effect of food on the PK of CBD (GWP42003-P) following a single dose of CBD (GWP42003-P) in healthy male and female subjects. To assess the changes from baseline in the Cannabis Withdrawal Scale (CWS) score To assess the changes from baseline in sleep disruption 0-10 Numerical Rating Scale (NRS) score. To assess the changes from baseline in Epworth Sleepiness Scale (ESS) score. To assess the changes from baseline in Columbia Suicide Severity Rating Scale (C SSRS) questionnaire (multiple dose only)	—

Measure

Time frame

To assess the pharmacokinetics (PK) of single ascending and multiple doses of CBD (GWP42003-P) in healthy male and female subjects. To assess the effect of food on the PK of CBD (GWP42003-P) following a single dose of CBD (GWP42003-P) in healthy male and female subjects. To assess the changes from baseline in the Cannabis Withdrawal Scale (CWS) score To assess the changes from baseline in sleep disruption 0-10 Numerical Rating Scale (NRS) score. To assess the changes from baseline in Epworth Sleepiness Scale (ESS) score. To assess the changes from baseline in Columbia Suicide Severity Rating Scale (C SSRS) questionnaire (multiple dose only)

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)