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

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2008

Interventions

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

Arms, Groups and Cohorts

  • Experimental: 1
    • Active Treatment
  • Placebo Comparator: 2
    • Placebo Treatment

Clinical Trial Outcome Measures

Primary Measures

  • Alanine Aminotransferase (ALT)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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
    • Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
    • Change from baseline to Day 14
  • Creatinine
    • Time Frame: 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)
    • Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
    • Change from baseline to Day 14
  • Reticulocytes
    • Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
    • Change from baseline to Day 14
  • Leucocytes
    • Time Frame: 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)
    • Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
    • QTcF interval greater than 450 ms
  • QTcF
    • Time Frame: 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)
    • Time Frame: 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))
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: Pre-dose on day -1 to day 15 (end of dosing)
    • t1/2 following 14 days’ dosing
  • Renal Clearance of Drug From Plasma (CLR)
    • Time Frame: Pre-dose on day -1 to day 15 (end of dosing)
    • CLR following 14 days’ dosing

Secondary Measures

  • Sputum Absolute Neutrophil Count
    • Time Frame: Pre-dose day -1 to post-dose on day 14
    • Change from baseline to Day 14 in absolute neutrophil count
  • Sputum Differential Neutrophil Count
    • Time Frame: Pre-dose day -1 to post-dose on day 14
    • Change from baseline to Day 14 in percentage neutrophil count
  • AZD9668 Sputum Concentrations
    • Time Frame: Pre-dose day -1 to post-dose on day 14
  • Quantitative Sputum Bacteriology
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kristina Panke, Principal Investigator, Parexel International GmbhH (CRO)

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