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A Two Week Study to Assess the Tolerability of AZD9668 in Chronic Obstructive Pulmonary Disease (COPD) Patients

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
AZD9668
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Chronic, obstructive, pulmonary, lung, respiratory disease, tolerability, placebo-controlled, pharmacokinetics, COPD

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Mild to moderate COPD
  • Smokers or ex-smokers
  • post-menopausal females

Exclusion Criteria:

  • Past history or current evidence of clinically significant heart disease
  • Lung disease other than COPD
  • Treatment with systemic steroids within 8 weeks of study visit 2
  • Treatment with antibiotics within 4 weeks of study visit 1 or study visit 2

Sites / Locations

  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Active Treatment

Placebo Treatment

Outcomes

Primary Outcome Measures

Alanine Aminotransferase (ALT)
ALT level greater than 3 times the upper limit of normal
Aspartate Aminotransferase (AST)
AST level greater than 3 times the upper limit of normal
Creatine Kinase (CK)
Change from baseline to Day 14
Total Bilirubin
Change from baseline to Day 14
Creatinine
Creatinine level greater than the upper limit of normal
Haemoglobin (Hb)
Change from baseline to Day 14
Reticulocytes
Change from baseline to Day 14
Leucocytes
Change from baseline to Day 14
QTcF (QT Interval Corrected for Heart Rate by Fridericia's Method)
QTcF interval greater than 450 ms
QTcF
QTcF change from baseline greater than 60 ms
FEV1 (Forced Expiratory Volume in the First Second)
Change from baseline to Day 14
Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post-dose (AUC(0-12))
AUC(0-12) following 14 days' dosing
Observed Peak or Maximum Plasma Concentration Following Drug Administration (Cmax)
Cmax following 14 days' dosing
Time to Reach Observed Peak or Maximum Concentration Following Oral Drug Administration (Tmax)
tmax following 14 days' dosing
Terminal Half-life of Drug in Plasma (t1/2)
t1/2 following 14 days' dosing
Renal Clearance of Drug From Plasma (CLR)
CLR following 14 days' dosing

Secondary Outcome Measures

Sputum Absolute Neutrophil Count
Change from baseline to Day 14 in absolute neutrophil count
Sputum Differential Neutrophil Count
Change from baseline to Day 14 in percentage neutrophil count
AZD9668 Sputum Concentrations
Quantitative Sputum Bacteriology
Number of patients with an increase in bacteriological count from Day -1 to Day 15

Full Information

First Posted
June 19, 2008
Last Updated
January 24, 2012
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00703391
Brief Title
A Two Week Study to Assess the Tolerability of AZD9668 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title
A 2-week, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Tolerability and Pharmacokinetics of Orally Administered AZD9668 in Patients With COPD
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the tolerability (effect of drug on body) and pharmacokinetics (effect of body on drug) of AZD9668 in patients with mild to moderate COPD

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Chronic, obstructive, pulmonary, lung, respiratory disease, tolerability, placebo-controlled, pharmacokinetics, COPD

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Active Treatment
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo Treatment
Intervention Type
Drug
Intervention Name(s)
AZD9668
Intervention Description
30mg oral tablets twice daily (bid) for 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matched placebo to 30mg oral tablet twice daily (bid) for 14 days
Primary Outcome Measure Information:
Title
Alanine Aminotransferase (ALT)
Description
ALT level greater than 3 times the upper limit of normal
Time Frame
Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Title
Aspartate Aminotransferase (AST)
Description
AST level greater than 3 times the upper limit of normal
Time Frame
Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Title
Creatine Kinase (CK)
Description
Change from baseline to Day 14
Time Frame
Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Title
Total Bilirubin
Description
Change from baseline to Day 14
Time Frame
Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Title
Creatinine
Description
Creatinine level greater than the upper limit of normal
Time Frame
Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Title
Haemoglobin (Hb)
Description
Change from baseline to Day 14
Time Frame
Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Title
Reticulocytes
Description
Change from baseline to Day 14
Time Frame
Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Title
Leucocytes
Description
Change from baseline to Day 14
Time Frame
Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Title
QTcF (QT Interval Corrected for Heart Rate by Fridericia's Method)
Description
QTcF interval greater than 450 ms
Time Frame
Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Title
QTcF
Description
QTcF change from baseline greater than 60 ms
Time Frame
Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Title
FEV1 (Forced Expiratory Volume in the First Second)
Description
Change from baseline to Day 14
Time Frame
Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Title
Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post-dose (AUC(0-12))
Description
AUC(0-12) following 14 days' dosing
Time Frame
Pre-dose on day -1 to day 15 (end of dosing)
Title
Observed Peak or Maximum Plasma Concentration Following Drug Administration (Cmax)
Description
Cmax following 14 days' dosing
Time Frame
Pre-dose on day -1 to day 15 (end of dosing)
Title
Time to Reach Observed Peak or Maximum Concentration Following Oral Drug Administration (Tmax)
Description
tmax following 14 days' dosing
Time Frame
Pre-dose on day -1 to day 15 (end of dosing)
Title
Terminal Half-life of Drug in Plasma (t1/2)
Description
t1/2 following 14 days' dosing
Time Frame
Pre-dose on day -1 to day 15 (end of dosing)
Title
Renal Clearance of Drug From Plasma (CLR)
Description
CLR following 14 days' dosing
Time Frame
Pre-dose on day -1 to day 15 (end of dosing)
Secondary Outcome Measure Information:
Title
Sputum Absolute Neutrophil Count
Description
Change from baseline to Day 14 in absolute neutrophil count
Time Frame
Pre-dose day -1 to post-dose on day 14
Title
Sputum Differential Neutrophil Count
Description
Change from baseline to Day 14 in percentage neutrophil count
Time Frame
Pre-dose day -1 to post-dose on day 14
Title
AZD9668 Sputum Concentrations
Time Frame
Pre-dose day -1 to post-dose on day 14
Title
Quantitative Sputum Bacteriology
Description
Number of patients with an increase in bacteriological count from Day -1 to Day 15
Time Frame
Pre-dose day -1 to post-dose on day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mild to moderate COPD Smokers or ex-smokers post-menopausal females Exclusion Criteria: Past history or current evidence of clinically significant heart disease Lung disease other than COPD Treatment with systemic steroids within 8 weeks of study visit 2 Treatment with antibiotics within 4 weeks of study visit 1 or study visit 2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristina Panke
Organizational Affiliation
Parexel International GmbhH (CRO)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Berlin
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

A Two Week Study to Assess the Tolerability of AZD9668 in Chronic Obstructive Pulmonary Disease (COPD) Patients

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