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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: AZD5672 (Drug); Moxifloxacin (Drug); placebo (Drug); AZD5672 (Drug); placebo (Drug); placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Mark Layton, Study Director, Affiliation: AstraZeneca R&D, Alderley Park, UK
Darren Wilbraham, Principal Investigator, Affiliation: Guys Drug Research Unit, Newcomen St, London

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.

Clinical Details

Official title: A Single-centre, Double-blind, Double-dummy, Randomised, Placebo-controlled, Four-period Crossover Study to Assess the Effect of Single Oral Doses of AZD5672 (600 mg and 150 mg) on QT/QTc Interval, Compared to Placebo, Using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome: Evaluate time-matched QTcF intervals of single dose AZD5672 600mg compared to placebo.

Secondary outcome:

Evaluate time-matched QTcF Intervals of single dose AZD5672 150mg compared to placebo.

To evaluate the change in time matched ECG parameters (QTcB, QTcX, RR, PR and QRS) of single dose AZD5672 600mg and 150mg compared to placebo

To further evaluate the safety and tolerability of single dose AZD5672 600mg and 150mg

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

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

Locations and Contacts

Research Site, London, United Kingdom
Additional Information

Starting date: April 2009
Last updated: July 15, 2009

Page last updated: August 23, 2015

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