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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
AZD5672
Moxifloxacin
placebo
AZD5672
placebo
placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Rheumatoid Arthritis focused on measuring QTcF, Crossover, ICH E14, QT/QTc prolongation, Moxifloxacin, QT/QTc Interval

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

A

B

C

D

Arm Description

600mg AZD5672 + Moxifloxacin placebo

100mg AZD5672 + Moxifloxacin placebo

AZD5672 placebo + Moxifloxacin 400mg

AZD5672 placebo + Moxifloxacin placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 23, 2009
Last Updated
July 15, 2009
Sponsor
AstraZeneca
Collaborators
Quintiles, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00887770
Brief Title
A Study to Investigate the Potential for AZD5672 to Affect the Electrical Conduction Pathways in the Heart
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 Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca
Collaborators
Quintiles, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
QTcF, Crossover, ICH E14, QT/QTc prolongation, Moxifloxacin, QT/QTc Interval

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
600mg AZD5672 + Moxifloxacin placebo
Arm Title
B
Arm Type
Experimental
Arm Description
100mg AZD5672 + Moxifloxacin placebo
Arm Title
C
Arm Type
Active Comparator
Arm Description
AZD5672 placebo + Moxifloxacin 400mg
Arm Title
D
Arm Type
Placebo Comparator
Arm Description
AZD5672 placebo + Moxifloxacin placebo
Intervention Type
Drug
Intervention Name(s)
AZD5672
Intervention Description
12 x 50mg tablet, oral, single dose
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin
Other Intervention Name(s)
Avelox
Intervention Description
1 x 400mg capsule, oral, single dose
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
12 x matched to AZD5672 50 mg tablet
Intervention Type
Drug
Intervention Name(s)
AZD5672
Intervention Description
3 x 50mg tablet, oral. single dose
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
9 x matched to AZD5672 50mg tablet
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
1 x matched to Moxifloxacin capsule
Primary Outcome Measure Information:
Title
Evaluate time-matched QTcF intervals of single dose AZD5672 600mg compared to placebo.
Time Frame
Up to 24 hours postdose
Secondary Outcome Measure Information:
Title
Evaluate time-matched QTcF Intervals of single dose AZD5672 150mg compared to placebo.
Time Frame
Up to 24 hours postdose
Title
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
Title
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.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Layton
Organizational Affiliation
AstraZeneca R&D, Alderley Park, UK
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Darren Wilbraham
Organizational Affiliation
Guys Drug Research Unit, Newcomen St, London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
London
Country
United Kingdom

12. IPD Sharing Statement

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

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