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AZD2115 Single Ascending Dose Study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD2115 |
|
| 2 | Placebo Comparator | Placebo to AZD2115 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2115 | Drug | Single dose, oral inhalation (nebuliser solution) |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the frequency of adverse events of inhaled single doses of AZD2115 | Measurements will be taken at screening | |
| To evaluate the laboratory safety assessments of inhaled single doses of AZD2115 | Measurements will be taken at screening | |
| To evaluate the vital signs of inhaled single doses of AZD2115 | Measurements will be taken at screening | |
| To evaluate the physical examination of inhaled single doses of AZD2115 | Measurements will be taken at screening | |
| To evaluate the ECG of inhaled single doses of AZD2115 | Measurements will be taken at screening | |
| To evaluate the frequency of adverse events of inhaled single doses of AZD2115 | Measurements will be taken pre-dose | |
| To evaluate the frequency of adverse events of inhaled single doses of AZD2115 | Measurements will be taken at multiple timelpoints during dosing day through to 48 hours post-dose | |
| To evaluate the frequency of adverse events of inhaled single doses of AZD2115 | Measurements will be taken at follow up 7-13 days post dose. | |
| To evaluate the laboratory safety assessments of inhaled single doses of AZD2115 | Measurements will be taken at pre-dose |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the pharmacokinetics of a single dose of AZD2115 by assessment of area under the curve over the time (AUC) and maximum concentration (Cmax). | Frequent sampling occasions during study days, before and up to 48 h after dosing | |
| To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - FEV1 |
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Inclusion Criteria:
Exclusion Criteria:
Prolonged QTcF >450 ms or shortened QTcF <340 ms or family history of long QT syndrome
Any clinically important abnormalities in heart rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes. This includes subjects with any of the following:
History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD2115 and/or excipients
History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
Serum potassium concentration of <3.80 mmol/L on admission (Day -1)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London | UK | United Kingdom |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D053120 | Respiratory Aspiration |
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Drug |
Single dose, oral inhalation (nebuliser solution) |
|
| To evaluate the laboratory safety assessments of inhaled single doses of AZD2115 | Measurements will be taken at multiple timelpoints during dosing day through to 48 hours post-dose |
| To evaluate the laboratory safety assessments of inhaled single doses of AZD2115 | Measurements will be taken at follow up 7-13 days post dose. |
| To evaluate the vital signs of inhaled single doses of AZD2115 | Measurements will be taken at pre-dose |
| To evaluate the vital signs of inhaled single doses of AZD2115 | Measurements will be taken at multiple timelpoints during dosing day through to 48 hours post-dose |
| To evaluate the vital signs of inhaled single doses of AZD2115 | Measurements will be taken at follow up 7-13 days post dose. |
| To evaluate the physical examination of inhaled single doses of AZD2115 | Measurements will be taken at pre-dose |
| To evaluate the physical examination of inhaled single doses of AZD2115 | Measurements will be taken at multiple timelpoints during dosing day through to 48 hours post-dose |
| To evaluate the physical examination of inhaled single doses of AZD2115 | Measurements will be taken at follow up 7-13 days post dose. |
| To evaluate the ECG of inhaled single doses of AZD2115 | Measurements will be taken at pre-dose |
| To evaluate the ECG of inhaled single doses of AZD2115 | Measurements will be taken at multiple timelpoints during dosing day through to 48 hours post-dose |
| To evaluate the ECG of inhaled single doses of AZD2115 | Measurements will be taken at follow up 7-13 days post dose. |
| Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose. |
| To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - potassium | Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose. |
| To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - glucose | Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose. |
| To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - systolic and diastolic blood pressure | Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose. |
| To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - pulse, heart rate | Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose. |
| To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - QTcF | Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |