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

Phase 2

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: AZD9668; Drug: Placebo

• Registration Number: NCT00703391
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-19
• Study First Submitted QC: 2008-06-20
• Study First Posted: 2008-06-23
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2010-11-30
• Results First Submitted QC: 2010-11-30
• Results First Posted: 2010-12-29
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-24
• Last Update Posted: 2012-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD9668	Active Treatment
2	Placebo	Placebo Treatment

Primary Outcome Measures

Name	Time	Method
Alanine Aminotransferase (ALT)	Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)	ALT level greater than 3 times the upper limit of normal
Aspartate Aminotransferase (AST)	Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)	AST level greater than 3 times the upper limit of normal
Creatine Kinase (CK)	Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)	Change from baseline to Day 14
Total Bilirubin	Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)	Change from baseline to Day 14
Creatinine	Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)	Creatinine level greater than the upper limit of normal
Haemoglobin (Hb)	Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)	Change from baseline to Day 14
Reticulocytes	Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)	Change from baseline to Day 14
Leucocytes	Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)	Change from baseline to Day 14
QTcF (QT Interval Corrected for Heart Rate by Fridericia's Method)	Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)	QTcF interval greater than 450 ms
QTcF	Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)	QTcF change from baseline greater than 60 ms
FEV1 (Forced Expiratory Volume in the First Second)	Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)	Change from baseline to Day 14
Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post-dose (AUC(0-12))	Pre-dose on day -1 to day 15 (end of dosing)	AUC(0-12) following 14 days' dosing
Observed Peak or Maximum Plasma Concentration Following Drug Administration (Cmax)	Pre-dose on day -1 to day 15 (end of dosing)	Cmax following 14 days' dosing
Time to Reach Observed Peak or Maximum Concentration Following Oral Drug Administration (Tmax)	Pre-dose on day -1 to day 15 (end of dosing)	tmax following 14 days' dosing
Terminal Half-life of Drug in Plasma (t1/2)	Pre-dose on day -1 to day 15 (end of dosing)	t1/2 following 14 days' dosing
Renal Clearance of Drug From Plasma (CLR)	Pre-dose on day -1 to day 15 (end of dosing)	CLR following 14 days' dosing

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇩🇪 Berlin, Germany