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

July 15, 2009 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
600mg AZD5672 + Moxifloxacin placebo
Drug: AZD5672
12 x 50mg tablet, oral, single dose
Drug: placebo
12 x matched to AZD5672 50 mg tablet
Drug: AZD5672
3 x 50mg tablet, oral. single dose
Drug: placebo
9 x matched to AZD5672 50mg tablet
Drug: placebo
1 x matched to Moxifloxacin capsule
EXPERIMENTAL: B
100mg AZD5672 + Moxifloxacin placebo
Drug: AZD5672
12 x 50mg tablet, oral, single dose
Drug: placebo
12 x matched to AZD5672 50 mg tablet
Drug: AZD5672
3 x 50mg tablet, oral. single dose
Drug: placebo
9 x matched to AZD5672 50mg tablet
Drug: placebo
1 x matched to Moxifloxacin capsule
ACTIVE_COMPARATOR: C
AZD5672 placebo + Moxifloxacin 400mg
Drug: placebo
12 x matched to AZD5672 50 mg tablet
Drug: placebo
9 x matched to AZD5672 50mg tablet
Drug: placebo
1 x matched to Moxifloxacin capsule
Drug: Moxifloxacin
1 x 400mg capsule, oral, single dose
Other Names:
  • Avelox
PLACEBO_COMPARATOR: D
AZD5672 placebo + Moxifloxacin placebo
Drug: placebo
12 x matched to AZD5672 50 mg tablet
Drug: placebo
9 x matched to AZD5672 50mg tablet
Drug: placebo
1 x matched to Moxifloxacin capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate time-matched QTcF intervals of single dose AZD5672 600mg compared to placebo.
Time Frame: Up to 24 hours postdose
Up to 24 hours postdose

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate time-matched QTcF Intervals of single dose AZD5672 150mg compared to placebo.
Time Frame: Up to 24 hours postdose
Up to 24 hours postdose
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
Time Frame: Up to 24 hours postdose
Up to 24 hours postdose
To further evaluate the safety and tolerability of single dose AZD5672 600mg and 150mg
Time Frame: Adverse events assessed throughout the whole study. Safety monitoring (BP, safety blood samples and ECG) conducted frequently throughout study and up to 72 hours post dose on treatment visits.
Adverse events assessed throughout the whole study. Safety monitoring (BP, safety blood samples and ECG) conducted frequently throughout study and up to 72 hours post dose on treatment visits.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Quintiles, Inc.

Investigators

  • Principal Investigator: Darren Wilbraham, Guys Drug Research Unit, Newcomen St, London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Study Completion (ACTUAL)

July 1, 2009

Study Registration Dates

First Submitted

April 23, 2009

First Submitted That Met QC Criteria

April 23, 2009

First Posted (ESTIMATE)

April 24, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 16, 2009

Last Update Submitted That Met QC Criteria

July 15, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1710C00006
  • Eudract No. 2009-009940-22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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