NCT00703391 - A Two Week Study to Assess the Tolerability of AZD9668 in Chronic Obstructive Pulmonary Disease (COPD) Patients | Crick | Crick

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

Phase 2CompletedNCT00703391

AstraZeneca18 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

18

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

30mg oral tablets twice daily (bid) for 14 days

Matched placebo to 30mg oral tablet twice daily (bid) for 14 days

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Berlin, Germany

Outcomes

Primary Outcomes

Alanine Aminotransferase (ALT)

ALT level greater than 3 times the upper limit of normal

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)

Reticulocytes

Change from baseline to Day 14

Time frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)

Leucocytes

Change from baseline to Day 14

Time frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)

Data from ClinicalTrials.gov

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