Clinical trial NCT00703391: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic
obstructive
pulmonary
lung
respiratory disease
tolerability
placebo-controlled
pharmacokinetics
COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-23
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


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

Primary outcomes:
measure: Alanine Aminotransferase (ALT)
timeFrame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
measure: Aspartate Aminotransferase (AST)
timeFrame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
measure: Creatine Kinase (CK)
timeFrame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
measure: Total Bilirubin
timeFrame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
measure: Creatinine
timeFrame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
measure: Haemoglobin (Hb)
timeFrame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
measure: Reticulocytes
timeFrame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
measure: Leucocytes
timeFrame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
measure: QTcF (QT Interval Corrected for Heart Rate by Fridericia's Method)
timeFrame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
measure: QTcF
timeFrame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
measure: FEV1 (Forced Expiratory Volume in the First Second)
timeFrame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
measure: Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post-dose (AUC(0-12))
timeFrame: Pre-dose on day -1 to day 15 (end of dosing)
measure: Observed Peak or Maximum Plasma Concentration Following Drug Administration (Cmax)
timeFrame: Pre-dose on day -1 to day 15 (end of dosing)
measure: Time to Reach Observed Peak or Maximum Concentration Following Oral Drug Administration (Tmax)
timeFrame: Pre-dose on day -1 to day 15 (end of dosing)
measure: Terminal Half-life of Drug in Plasma (t1/2)
timeFrame: Pre-dose on day -1 to day 15 (end of dosing)
measure: Renal Clearance of Drug From Plasma (CLR)
timeFrame: Pre-dose on day -1 to day 15 (end of dosing)
Secondary outcomes:
measure: Sputum Absolute Neutrophil Count
timeFrame: Pre-dose day -1 to post-dose on day 14
measure: Sputum Differential Neutrophil Count
timeFrame: Pre-dose day -1 to post-dose on day 14
measure: AZD9668 Sputum Concentrations
timeFrame: Pre-dose day -1 to post-dose on day 14
measure: Quantitative Sputum Bacteriology
timeFrame: Pre-dose day -1 to post-dose on day 15
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Research Site
Study officials:
affiliation: Parexel International GmbhH (CRO)
name: Kristina Panke
role: PRINCIPAL_INVESTIGATOR
References: