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

Completed

Conditions: Epilepsy
10039911

Registration Number: NL-OMON42686

Lead Sponsor: GW Research Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 56

Inclusion Criteria

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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