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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Active Treatment |
|
| 2 | Placebo Comparator | Placebo Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD9668 | Drug | 30mg oral tablets twice daily (bid) for 14 days |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Reticulocytes | Change from baseline to Day 14 | Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Sputum Absolute Neutrophil Count | Change from baseline to Day 14 in absolute neutrophil count | Pre-dose day -1 to post-dose on day 14 |
| Sputum Differential Neutrophil Count | Change from baseline to Day 14 in percentage neutrophil count |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristina Panke | Parexel International GmbhH (CRO) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Berlin | Germany |
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First patient enrolled: 11 June 2008. Last patient completed: 09 October 2008. Single-centre study performed at a Clinical Pharmacology Unit
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD9668 | AZD9668 2x30mg oral tablets twice daily (bid) for 14 days |
| FG001 | Placebo | Matched placebo tablets twice daily (bid) for 14 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD9668 | AZD9668 2x30mg oral tablets twice daily (bid) for 14 days |
| BG001 | Placebo | Matched placebo tablets twice daily (bid) for 14 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Alanine Aminotransferase (ALT) | ALT level greater than 3 times the upper limit of normal | Posted | Number | Participants | Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZD9668 | AZD9668 2x30mg oral tablets twice daily (bid) for 14 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C568080 | N-((5-(methanesulfonyl)pyridin-2-yl)methyl)-6-methyl-5-(1-methyl-1H-pyrazol-5-yl)-2-oxo-1-(3-(trifluoromethyl)phenyl)-1,2-dihydropyridine-3-carboxamide |
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| Drug |
Matched placebo to 30mg oral tablet twice daily (bid) for 14 days |
|
| Leucocytes | Change from baseline to Day 14 | Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Renal Clearance of Drug From Plasma (CLR) | CLR following 14 days' dosing | Pre-dose on day -1 to day 15 (end of dosing) |
| Pre-dose day -1 to post-dose on day 14 |
| AZD9668 Sputum Concentrations | Pre-dose day -1 to post-dose on day 14 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Aspartate Aminotransferase (AST) | AST level greater than 3 times the upper limit of normal | Posted | Number | Participants | Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) |
|
|
|
| Primary | Creatine Kinase (CK) | Change from baseline to Day 14 | Posted | Mean | Standard Deviation | IU/L | Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) |
|
|
|
| Primary | Total Bilirubin | Change from baseline to Day 14 | Posted | Mean | Standard Deviation | micromol/L | Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) |
|
|
|
| Primary | Creatinine | Creatinine level greater than the upper limit of normal | Posted | Number | Participants | Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) |
|
|
|
| Primary | Haemoglobin (Hb) | Change from baseline to Day 14 | Posted | Mean | Standard Deviation | g/L | Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) |
|
|
|
| Primary | Reticulocytes | Change from baseline to Day 14 | Posted | Mean | Standard Deviation | relative particle count (%) | Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) |
|
|
|
| Primary | Leucocytes | Change from baseline to Day 14 | Posted | Mean | Standard Deviation | 10**9/L | Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) |
|
|
|
| Primary | QTcF (QT Interval Corrected for Heart Rate by Fridericia's Method) | QTcF interval greater than 450 ms | Posted | Number | Participants | Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) |
|
|
|
| Primary | QTcF | QTcF change from baseline greater than 60 ms | Posted | Number | Participants | Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) |
|
|
|
| Secondary | Sputum Absolute Neutrophil Count | Change from baseline to Day 14 in absolute neutrophil count | Posted | Median | Full Range | 10**9/L | Pre-dose day -1 to post-dose on day 14 |
|
|
|
| Secondary | Sputum Differential Neutrophil Count | Change from baseline to Day 14 in percentage neutrophil count | Posted | Median | Full Range | Percentage | Pre-dose day -1 to post-dose on day 14 |
|
|
|
| Secondary | AZD9668 Sputum Concentrations | Posted | Geometric Mean | Full Range | nM | Pre-dose day -1 to post-dose on day 14 |
|
|
|
| Secondary | Quantitative Sputum Bacteriology | Number of patients with an increase in bacteriological count from Day -1 to Day 15 | Posted | Number | Participants | Pre-dose day -1 to post-dose on day 15 |
|
|
|
| Primary | FEV1 (Forced Expiratory Volume in the First Second) | Change from baseline to Day 14 | Posted | Mean | Standard Deviation | L | Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) |
|
|
|
| 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 | Posted | Geometric Mean | Full Range | nM.h | Pre-dose on day -1 to day 15 (end of dosing) |
|
|
|
| Primary | Observed Peak or Maximum Plasma Concentration Following Drug Administration (Cmax) | Cmax following 14 days' dosing | Posted | Geometric Mean | Full Range | nM | Pre-dose on day -1 to day 15 (end of dosing) |
|
|
|
| Primary | Time to Reach Observed Peak or Maximum Concentration Following Oral Drug Administration (Tmax) | tmax following 14 days' dosing | Posted | Median | Full Range | hours | Pre-dose on day -1 to day 15 (end of dosing) |
|
|
|
| Primary | Terminal Half-life of Drug in Plasma (t1/2) | t1/2 following 14 days' dosing | Posted | Median | Full Range | hours | Pre-dose on day -1 to day 15 (end of dosing) |
|
|
|
| Primary | Renal Clearance of Drug From Plasma (CLR) | CLR following 14 days' dosing | Posted | Geometric Mean | Full Range | L/h | Pre-dose on day -1 to day 15 (end of dosing) |
|
|
|
| 0 |
| 12 |
| 5 |
| EG001 | Placebo | Matched placebo tablets twice daily (bid) for 14 days | 0 | 6 | 4 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 10.0 |
|
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Back pain | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |