NCT00887770

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_1 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

July 16, 2009

Status Verified

July 1, 2009

First QC Date

April 23, 2009

Last Update Submit

July 15, 2009

Conditions

Rheumatoid Arthritis

Keywords

QTcFCrossoverICH E14QT/QTc prolongationMoxifloxacinQT/QTc Interval

Outcome Measures

Primary Outcomes (1)

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

    Up to 24 hours postdose

Secondary Outcomes (3)

  • 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

    Up to 24 hours postdose

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

    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.

Study Arms (4)

A

EXPERIMENTAL

600mg AZD5672 + Moxifloxacin placebo

Drug: AZD5672Drug: placebo

B

EXPERIMENTAL

100mg AZD5672 + Moxifloxacin placebo

Drug: AZD5672Drug: placebo

C

ACTIVE COMPARATOR

AZD5672 placebo + Moxifloxacin 400mg

Drug: MoxifloxacinDrug: placebo

D

PLACEBO COMPARATOR

AZD5672 placebo + Moxifloxacin placebo

Drug: placebo

Interventions

AZD5672DRUG

12 x 50mg tablet, oral, single dose

A
MoxifloxacinDRUG

1 x 400mg capsule, oral, single dose

Also known as: Avelox
C
placeboDRUG

12 x matched to AZD5672 50 mg tablet

CD

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

London, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

N-(1-(3-(3,5-difluorophenyl)-3-(4-methanesulfonylphenyl)propyl)piperidin-4-yl)-N-ethyl-2-(4-methanesulfonylphenyl)acetamideMoxifloxacin

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Mark Layton

    AstraZeneca R&D, Alderley Park, UK

    STUDY DIRECTOR

  • Darren Wilbraham

    Guys Drug Research Unit, Newcomen St, London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 23, 2009

First Posted

April 24, 2009

Study Start

April 1, 2009

Study Completion

July 1, 2009

Last Updated

July 16, 2009

Record last verified: 2009-07

Locations

GB(1)