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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023338-22 |
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The purpose of this research study is to evaluate the effect of AZD1981 on the electrical activity of the heart, in particular when the heart muscle is relaxed during a heart beat cycle. The effect of AZD1981 will be compared to a licensed antibiotic (moxifloxacin) which is well known to affect the electrical activity of the heart, but this effect is known to be at levels that are safe at the dose used in this study. The investigators will also compare the effects of AZD1981 with a "dummy drug" (placebo). The investigators will also be evaluating how safe and well tolerated AZD1981 is and how much AZD1981 enters the blood circulation by collecting blood during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1981, 2000mg | Drug | Single oral dose, tablets |
| |
| AZD1981, 200mg |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of a single supra maximal therapeutic dose of AZD1981on QT interval - QTcF | dECG and telemetry measurements taken pre-dose and up to and including 48 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of a therapeutic dose of AZD1981on QT interval -QTcF | dECG and telemetry measurements taken pre-dose and up to and including 48 hours post dose | |
| To evaluate the effect of AZD1981 on additional electrocardiogram variables - QTcB -RR PR QRS. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Researche Site | London | UK | United Kingdom |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C569518 | AZD1981 |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Drug |
Single oral dose, tablets |
|
| Moxifloxacin, 400mg | Drug | Single oral dose, capsule |
|
| Placebo | Drug | Single oral dose, tablets |
|
| dECG and telemetry measurements taken pre-dose and up to and including 48 hours post dose |
| To evaluate the safety and tolerability of single doses of AZD1981 -frequency of adverse events - laboratory safety assessments - vital signs - physical examination - ECG. | Adverse events recorded at all four residential visits (one week washout between visits) and at follow up (7-10 days following last residential visit) |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |