NCT01222442

Brief Summary

The purpose of this research study is to evaluate the effect of AZD3199 on the electrical activity of the heart. The effect of AZD3199 will be compared to a licensed antibiotic (moxifloxacin). Moxifloxacin effects on the electrical activity of the heart are well known. Safety and tolerability of AZD3199 and how much AZD3199 enters the blood circulation will also be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_1 chronic-obstructive-pulmonary-disease

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

First Submitted

Initial submission to the registry

October 12, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 18, 2010

Completed
14 days until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

February 16, 2011

Status Verified

February 1, 2011

Enrollment Period

3 months

First QC Date

October 12, 2010

Last Update Submit

February 15, 2011

Conditions

Chronic Obstructive Pulmonary DiseaseLung Disease

Keywords

Respiratory diseaseBronchiolitisEmphysemaLung disease causing persistent narrowing of the airways

Outcome Measures

Primary Outcomes (1)

  • To investigate the effect of AZD3199 on the QT interval

    QTcF or QTcI (algorithm based decision)

    Throughout the study

Secondary Outcomes (3)

  • To investigate the effect of AZD3199 on additional electrocardiogram variables

    Throughout the study

  • To assess the pharmacokinetics of single doses of AZD3199.

    Throughout the study

  • To evaluate the safety and tolerability of single doses of AZD3199.

    Throughout the study

Study Arms (4)

1

EXPERIMENTAL

400 µg AZD3199 + moxifloxacin placebo

Drug: AZD3199

2

EXPERIMENTAL

1200 µg AZD3199 + moxifloxacin placebo

Drug: AZD3199

3

ACTIVE COMPARATOR

AZD3199 placebo + moxifloxacin 400 mg

Drug: Moxifloxacin

4

PLACEBO COMPARATOR

AZD3199 placebo + moxifloxacin placebo

Other: Placebo comparator

Interventions

AZD3199DRUG

Single dose, oral inhalation

12
MoxifloxacinDRUG

Single dose, oral encapsulated tablet

Also known as: Avelox®
3
Placebo comparatorOTHER

Single dose, oral inhalation

4

Eligibility Criteria

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

You may qualify if:

  • Healthy male subjects aged 18 to 45 years (inclusive)
  • Have a body mass index (BMI) between 19 and 30 kg/m2 and a body weight between 60 and 100 kg.
  • Be a non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start.
  • Be able to inhale from the Turbuhaler inhaler according to given instructions.

You may not qualify if:

  • Any clinically significant disease or disorder
  • Any clinically relevant abnormal findings at screening examination
  • History of additional risk factors for Torsade de Pointes (eg, heart failure, hypokalaemia, or family history of long QT syndrome).
  • Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

London, UK, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveLung DiseasesRespiration DisordersBronchiolitisEmphysema

Interventions

AZD-3199Moxifloxacin

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchitisRespiratory Tract InfectionsInfectionsBronchial Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Carin Jorup, MD

    AstraZeneca R&D, Lund, Sweden

    STUDY DIRECTOR

  • Leonard Siew, MB CHB

    Quintiles Drug Research Unit at Guy's Hospital, London

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 12, 2010

First Posted

October 18, 2010

Study Start

November 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

February 16, 2011

Record last verified: 2011-02

Locations

GB(1)