A Study to Investigate the Potential for AZD5672 to Affec... | NCT00887770

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

NCT00887770

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jul 16, 2009Estimated

Enrollment

64Estimated

Phase

Phase 1

Conditions

Rheumatoid Arthritis

Interventions

AZD5672
Moxifloxacin
placebo
AZD5672
placebo
placebo

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Eudract No. 2009-009940-22

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

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Not provided

Completion Date

Jul 2009Actual

First Submitted Date

Apr 23, 2009

First Submission Date that Met QC Criteria

Apr 23, 2009

First Posted Date

Apr 24, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2009

Last Update Posted Date

Jul 16, 2009Estimated

Name	Class
Quintiles, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	600mg AZD5672 + Moxifloxacin placebo	Drug: AZD5672 Drug: placebo
B	Experimental	100mg AZD5672 + Moxifloxacin placebo	Drug: AZD5672 Drug: placebo
C	Active Comparator	AZD5672 placebo + Moxifloxacin 400mg	Drug: Moxifloxacin Drug: placebo
D	Placebo Comparator	AZD5672 placebo + Moxifloxacin placebo	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZD5672	Drug	12 x 50mg tablet, oral, single dose	A
Moxifloxacin

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark Layton	AstraZeneca R&D, Alderley Park, UK	Study Director
Darren Wilbraham	Guys Drug Research Unit, Newcomen St, London	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		London			United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C553747	N-(1-(3-(3,5-difluorophenyl)-3-(4-methanesulfonylphenyl)propyl)piperidin-4-yl)-N-ethyl-2-(4-methanesulfonylphenyl)acetamide
D000077266	Moxifloxacin

Ancestor Terms

ID	Term
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones
D011804	Quinolines

Browse Leaves

Not provided

Browse Branches

Not provided