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Sativex Thorough QT/QTc Study

NCT01322139 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2023-04-10

No results posted yet for this study

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.

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01322139 on ClinicalTrials.gov