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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00703391
• Other study ID #: D0520C00002
• Status: Completed
• Phase: Phase 2
• First received: June 19, 2008
• Last updated: January 24, 2012
• Start date: June 2008
• Est. completion date: September 2008

Study information

• Verified date: January 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• AZD9668
30mg oral tablets twice daily (bid) for 14 days
• Placebo
Matched placebo to 30mg oral tablet twice daily (bid) for 14 days

Locations

Country	Name	City	State
Germany	Research Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Primary	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)	Yes
Primary	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)	Yes
Primary	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)	Yes
Primary	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)	Yes
Primary	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)	Yes
Primary	Reticulocytes	Change from baseline to Day 14	Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)	Yes
Primary	Leucocytes	Change from baseline to Day 14	Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)	Yes
Primary	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)	Yes
Primary	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)	Yes
Primary	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)	Yes
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	Renal Clearance of Drug From Plasma (CLR)	CLR following 14 days' dosing	Pre-dose on day -1 to day 15 (end of dosing)	No
Secondary	Sputum Absolute Neutrophil Count	Change from baseline to Day 14 in absolute neutrophil count	Pre-dose day -1 to post-dose on day 14	Yes
Secondary	Sputum Differential Neutrophil Count	Change from baseline to Day 14 in percentage neutrophil count	Pre-dose day -1 to post-dose on day 14	Yes
Secondary	AZD9668 Sputum Concentrations		Pre-dose day -1 to post-dose on day 14	No
Secondary	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	Yes