A SINGLE ORAL DOSE, RANDOMIZED, DOUBLE-BLIND, PLACEBO- AND POSITIVE CONTROLLED, 4-WAY CROSSOVER STUDY TO INVESTIGATE THE EFFECT OF CANNABIDIOL (GWP42003-P) ON THE QTC INTERVAL IN HEALTHY SUBJECTS

Completed

• Conditions: Epilepsy; 10039911

• Registration Number: NL-OMON42632
• Lead Sponsor: B.1.2 Name of the person to contact:

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

healthy male/ female subjects
18-55 yrs, inclusive
BMI: 18.0 en 30.0 kg/m2 inclusive

Exclusion Criteria

History and/or family history of congenital long QT syndrome, unexplained syncope or other additional risks for Torsade de Pointes, hypokalemia or sudden death. Clinically significant ECG abnormalities.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the effect of single oral dose administration of CBD (GWP42003-P) 750<br /><br>mg and 4500 mg on the QT/QTc interval, relative to placebo in healthy adult<br /><br>male and female subjects. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate the safety and tolerability and PK of a single therapeutic and<br /><br>supratherapeutic oral dose of CBD (GWP42003-P) in healthy adult male and female<br /><br>subjects.<br /><br><br /><br>To evaluate assay sensitivity (i.e. to evaluate the effect of a positive<br /><br>control, a single oral dose of moxifloxacin [400 mg], on the QT/QTc interval in<br /><br>healthy subjects).<br /><br><br /><br>To assess the effects of a single therapeutic and supratherapeutic oral dose of<br /><br>CBD (GWP42003-P) on non QT interval ECG parameters (HR and RR, PR and QRS<br /><br>intervals) in healthy subjects.<br /><br><br /><br>To determine the PK of CBD and its major metabolites following a single<br /><br>therapeutic and supratherapeutic oral dose of CBD (GWP42003-P).<br /><br><br /><br>To determine the plasma concentration-effect relationship for CBD and its<br /><br>metabolites on the QT/QTc interval in healthy subjects.</p><br>