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A study in healthy subjects and mild asthmatics to investigate Pharmacokinetics of AZD5423 when administered in different ways.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD5423 iv |
|
| 2 | Experimental | AZD5423 inhalation, Spira |
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| 3 | Experimental | AZD5423 inhalation I-neb |
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| 4 | Experimental | AZD5423 oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD5423 | Drug | solution for injection, administered as intravenous infusion Corr to total dose of 250µg AZD5423 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of AZD5423 measured by: Absolute bioavailability (F) | Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period | |
| Pharmacokinetics of AZD5423 measured by: Pulmonary bioavailability (Fpulmonary) | Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period | |
| Pharmacokinetics of AZD5423 measured by: Oral bioavailability after inhaled treatments (Foral) | Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period | |
| Pharmacokinetics of AZD5423 measured by: Area under the plasma concentration-time curve from time zero to infinity (AUC). | Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the pharmacokinetics between healthy subjects and asthma patients and estimate the basic pharmacokinetic parameters of AZD5423 by measuring e.g. maximum plasma concentration, Cmax | Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period | |
| To evaluate the safety and tolerability of AZD5423 measured by adverse events, laboratory variables, physical examination, electrocardiograms, blood pressure and pulse, and spirometry. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darren Wilbraham, Dr | Quintiles Drug Research Unit at Guy's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Unit | London | SE1 1YR | United Kingdom |
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| Label | URL |
|---|---|
| CSR Synopsis | View source |
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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 |
|---|---|
| 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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| AZD5423 | Drug | nebuliser suspension, inhaled via Spira, corr to approximately 300 µg lung deposited dose AZD5423 |
|
| AZD5423 | Drug | nebuliser suspension, inhaled via I-neb, corr to approximately 300 µg lung deposited dose AZD5423 |
|
| AZD5423 | Drug | nebuliser suspension to be administered orally, corr to a total dose of 1200 µg AZD5423 |
|
To evaluate the safety and tolerability of AZD5423 measured by (Adverse events) (Laboratory variables) (Physical examination) (Electrocardiograms) (blood pressure and pulse) (Spirometry) |
| From screening to follow-up |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |