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The purpose of this research study is to evaluate the effect of AZD3199 on the electrical activity of the heart. The effect of AZD3199 will be compared to a licensed antibiotic (moxifloxacin). Moxifloxacin effects on the electrical activity of the heart are well known. Safety and tolerability of AZD3199 and how much AZD3199 enters the blood circulation will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 400 µg AZD3199 + moxifloxacin placebo |
|
| 2 | Experimental | 1200 µg AZD3199 + moxifloxacin placebo |
|
| 3 | Active Comparator | AZD3199 placebo + moxifloxacin 400 mg |
|
| 4 | Placebo Comparator | AZD3199 placebo + moxifloxacin placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD3199 | Drug | Single dose, oral inhalation |
| |
| Moxifloxacin |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the effect of AZD3199 on the QT interval | QTcF or QTcI (algorithm based decision) | Throughout the study |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the effect of AZD3199 on additional electrocardiogram variables |
| Throughout the study |
| To assess the pharmacokinetics of single doses of AZD3199. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carin Jorup, MD | AstraZeneca R&D, Lund, Sweden | Study Director |
| Leonard Siew, MB CHB | Quintiles Drug Research Unit at Guy's Hospital, London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London | UK | United Kingdom |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D008171 | Lung Diseases |
| D012120 | Respiration Disorders |
| D001988 | Bronchiolitis |
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| C544523 | AZD-3199 |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Drug |
Single dose, oral encapsulated tablet |
|
|
| Placebo comparator | Other | Single dose, oral inhalation |
|
| Throughout the study |
| To evaluate the safety and tolerability of single doses of AZD3199. |
| Throughout the study |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |