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The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5423 following single ascending dose administrations in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Drug: AZD5423 |
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| B | Placebo Comparator | Drug: Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD5423 | Drug | Solution for nebulisation, inhaled. Each subject will receive a single-dose of AZD5423 or placebo. Starting dose 8.4µg (lung deposited dose) with up to 8 dose escalations not exceeding AstraZeneca pre-defined exposure limits. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab), lung function and physical examination | Frequent sampling occasions during study days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics - Maximum plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration-time curve from zero to the time of the last measurable concentration [AUC(0-t)] and from zero to infinity (AUC) | Frequent sampling occasions during study days | |
| Add'l pharmacokinetics - Terminal rate constant (λz); terminal half-life (t½λz), Apparent plasma clearance (CL/F), apparent volume of distribution during terminal phase (Vz/F), mean residence time (MRT). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorup Carin | AstraZeneca R&D, Lund, Sweden | Study Director |
| Darren Wilbraham | Guy's Drug Research Unit, Quintiles Ltd, London, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London | United Kingdom |
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| Label | URL |
|---|---|
| Study Synopsis | View source |
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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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| ID | Term |
|---|---|
| C587250 | 2,2,2-trifluoro-N-(1-((1-(4-fluorophenyl)-1H-indazol-5-yl)oxy)-1-(3-methoxyphenyl)-2-propanyl)acetamide |
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| Placebo | Drug | Solution for nebulisation, inhaled. Each subject will receive a single-dose. |
|
| Frequent sampling occasions during study days |
| Pharmacodynamics - Plasma cortisol concentrations | Frequent sampling occasions during study days |