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

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 - Cannabidiol (GWP42003-P) TQT Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42632

Enrollment

Registered

2015-10-05

Start date

2015-10-27

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 study will consist of 4 periods during which the volunteers will receive a single dose of CBD twice (once a normal dose and once a high dose), CBD matching placebo or moxifloxacin. A placebo is

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)