Overview

A Study to Investigate the Potential for AZD5672 to Affect the Electrical Conduction Pathways in the Heart

Status:
Completed
Trial end date:
2009-07-01
Target enrollment:
0
Participant gender:
Male
Summary
This study is being performed to investigate the potential for AZD5672 to affect the electrical conduction pathways in the heart. AZD5672 will be compared against a drug (moxifloxacin - a licensed antibiotic) known to have a detectable but safe change on the electrical conduction of the heart.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
AstraZeneca
Collaborator:
Quintiles, Inc.
Treatments:
Fluoroquinolones
Moxifloxacin
N-(1-(3-(3,5-difluorophenyl)-3-(4-methanesulfonylphenyl)propyl)piperidin-4-yl)-N-ethyl-2-(4-methanesulfonylphenyl)acetamide
Norgestimate, ethinyl estradiol drug combination
Criteria
Inclusion Criteria:

- Body Mass Index (BMI) between 18 and 30 kg/m2 and a minimum weight of 50kg.

- Non-smoker

Exclusion Criteria:

- Marked QTc prolongation at baseline e.g. repeated demonstration of QTc interval >450ms
or marked shortening of QTcF <350ms

- Any clinically important abnormalities in rhythm, conduction or morphology of resting
ECG that may interfere with the interpretation of the QTc Interval changes

- Use of concomitant medications that prolong QT/QTc interval