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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: AZD9668; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Active Treatment	Drug: AZD9668; 30mg oral tablets twice daily (bid) for 14 days
Placebo Comparator: 2; Placebo Treatment	Drug: Placebo; Matched placebo to 30mg oral tablet twice daily (bid) for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alanine Aminotransferase (ALT)	ALT level greater than 3 times the upper limit of normal	Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Aspartate Aminotransferase (AST)	AST level greater than 3 times the upper limit of normal	Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Creatine Kinase (CK)	Change from baseline to Day 14	Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Total Bilirubin	Change from baseline to Day 14	Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Creatinine	Creatinine level greater than the upper limit of normal	Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Haemoglobin (Hb)	Change from baseline to Day 14	Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Reticulocytes	Change from baseline to Day 14	Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Leucocytes	Change from baseline to Day 14	Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
QTcF (QT Interval Corrected for Heart Rate by Fridericia's Method)	QTcF interval greater than 450 ms	Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
QTcF	QTcF change from baseline greater than 60 ms	Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
FEV1 (Forced Expiratory Volume in the First Second)	Change from baseline to Day 14	Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
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	Pre-dose on day -1 to day 15 (end of dosing)
Observed Peak or Maximum Plasma Concentration Following Drug Administration (Cmax)	Cmax following 14 days' dosing	Pre-dose on day -1 to day 15 (end of dosing)
Time to Reach Observed Peak or Maximum Concentration Following Oral Drug Administration (Tmax)	tmax following 14 days' dosing	Pre-dose on day -1 to day 15 (end of dosing)
Terminal Half-life of Drug in Plasma (t1/2)	t1/2 following 14 days' dosing	Pre-dose on day -1 to day 15 (end of dosing)
Renal Clearance of Drug From Plasma (CLR)	CLR following 14 days' dosing	Pre-dose on day -1 to day 15 (end of dosing)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sputum Absolute Neutrophil Count	Change from baseline to Day 14 in absolute neutrophil count	Pre-dose day -1 to post-dose on day 14
Sputum Differential Neutrophil Count	Change from baseline to Day 14 in percentage neutrophil count	Pre-dose day -1 to post-dose on day 14
AZD9668 Sputum Concentrations		Pre-dose day -1 to post-dose on day 14
Quantitative Sputum Bacteriology	Number of patients with an increase in bacteriological count from Day -1 to Day 15	Pre-dose day -1 to post-dose on day 15

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Kristina Panke, Parexel International GmbhH (CRO)

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: June 19, 2008
• First Submitted That Met QC Criteria: June 20, 2008
• First Posted (Estimate): June 23, 2008

Study Record Updates

• Last Update Posted (Estimate): January 26, 2012
• Last Update Submitted That Met QC Criteria: January 24, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: tolerability; lung; COPD; pharmacokinetics; Chronic; respiratory disease; placebo-controlled; obstructive; pulmonary
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: D0520C00002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No