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| ID | Type | Description | Link |
|---|---|---|---|
| Eudract number 2011-002402-75 |
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This study will investigate the safety and tolerability of AZD2115 following administration of multiple ascending doses.
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Inhaled Doses of AZD2115 in Healthy Male Subjects.
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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 | Multiple dose, oral inhalation (nebuliser solution) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Description of the safety profile in terms of adverse events, blood pressure, pulse, temperature, ECG (Electrocardiogram), lung function (Spirometry), physical examination, safety labs | No formal statistical tests will be performed. Abnormalities will be listed without statistical analysis | baseline, up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Description of the pharmacokinetics (PK) of AZD2115 in terms of area under the curve over the time (AUC) and maximum concentration (Cmax) and terminal half-life | PK samples collected post-dose at 5mins, 20mins, 40mins, 1hr, 1.5hrs, 2 hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs 36 hrs, 48hrs | day 1 |
| Description of pharmacokinetics (PK) of AZD2115 in terms of Cmax, area under the plasma concentration-time curve from zero to the end of the dosing interval (AUC(0-Ï„)) |
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Inclusion Criteria:
Exclusion Criteria:
Abnormal vital signs, after 10 minutes supine rest, defined as any of the following:
Prolonged QTcF >450 ms or shortened QTcF <340 ms or family history of long QT syndrome
Serum potassium concentration of < 3.80 mmol/L on admission (Day -1)
History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with the same class to AZD2115 or to excipients
History or presence of gastrointestinal, pulmonary, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London | UK | United Kingdom |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo |
| Drug |
Multiple dose, oral inhalation (nebuliser solution) |
|
PK samples collected post-dose at 5mins, 20mins, 40mins, 1hr, 1.5hrs, 2 hrs, 4hrs, 6hrs, 8hrs, 12hrs, 24hrs 36 hrs, 48hrs 72hrs, 96hrs, 120hrs and 168hrs. |
| day 17 |
| Description of achievement of plasma drug concentration steady state | An exploratory analysis of achievement of steady state will be evaluated graphically. | PK samples collected pre-dose on day 1, day 4, day 6, day 10, day 14, day 17 |
| Description of pharmacodynamics of AZD2115 in terms of FEV1 (forced expiratory volume in the first second), FVC (forced vital capacity), potassium, glucose, systolic and diastolic blood pressure, pulse rate, heart rate, QTcF | QTcF defined as QT interval corrected for heart rate using Fridericia's formula | day 1, day 17 |