Sativex Thorough QT/QTc Study

PHASE1CompletedINTERVENTIONAL
Enrollment

258

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

June 30, 2008

Study Completion Date

June 30, 2008

Conditions
Effects of Sativex on ECG
Interventions
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.

Trial Locations (1)

M5V 2T3

DecisionLine Clinical Research Corporation, Toronto

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY