NCT01322139

Sativex Thorough QT/QTc Study

A Multiple-Dose, Randomized, Double-Blind, Placebo- and Active-Controlled, Four-Arm, Parallel Group Thorough QT/QTc Study to Evaluate the Electrophysiologic Effects of Sativex.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study was to evaluate effects of Sativex on electrocardiogram (ECG) traces when administered at its therapeutic dose of 8 sprays per day and at multiples of the therapeutic dose (24 or 36 sprays per day), and to evaluate its safety and tolerability.

Detailed description

This is a multiple-dose, randomized, double-blind, double-dummy, placebo- and active-controlled, four arm, parallel group study to evaluate the effect of Sativex on the QT/QTc interval. Within 30 days of screening, eligible subjects were randomized to one of four treatment groups. Baseline ECG measurements were recorded at specified times and the following day, subjects commenced five days treatment with Sativex or placebo. On Day 5, subjects then received either moxifloxacin 400 mg (Group 4) or moxifloxacin placebo (Groups 1, 2 and 3). Triplicate ECG measurements and pharmacokinetic samples were collected on Day 5. On days 1-5, Safety ECG measurements were also collected at pre-dose and 2 hours post-dose. Subjects returned to the study centre for an outpatient safety follow-up visit approximately 10-14 days after their last dose of study medication.

Conditions

• Effects of Sativex on ECG

Interventions

Type	Name	Description
DRUG	Placebo spray and oral moxifloxacin placebo	24 or 36 placebo sprays (12 or 18 sprays twice daily every 12 hours) for 5 days and single oral moxifloxacin placebo on Day 5.
DRUG	Sativex spray and oral moxifloxacin placebo	8 Sativex sprays (4 sprays twice daily every 12 hours) + 16 or 28 placebo sprays (8 or 14 sprays twice daily every 12 hours) for 5 days and single oral moxifloxacin placebo on Day 5.
DRUG	Sativex spray and oral moxifloxacin placebo	24 or 36 Sativex sprays (12 or 18 sprays twice daily every 12 hours) for 5 days and single oral moxifloxacin placebo on Day 5.
DRUG	Placebo spray and moxifloxacin	24 or 36 placebo sprays (12 or 18 sprays twice daily every 12 hours) for 5 days and single oral moxifloxacin 400 mg tablet on Day 5.

Timeline

• Start date: 2007-12-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2011-03-24
• Last updated: 2023-04-10

Locations

1 site across 1 country: Canada