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| ID | Type | Description | Link |
|---|---|---|---|
| Eudract 2012-002307-17 |
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The purpose of this study is to look at drug levels of AZD5423 in blood when the drug is administered in different ways - orally, intravenously or inhaled (with four different devices), to healthy subjects
A Phase I, Single Centre, Open, Partly Randomised, Crossover Study in Healthy Subjects to Evaluate AZD5423 Absolute Pulmonary Bioavailability when Administered Inhaled via a New Dry Powder Inhaler, Turbuhaler, Spira nebulizer and I-neb AAD system
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD5423 iv |
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| 2 | Experimental | AZD5423 inhalation, Spira |
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| 3 | Experimental | AZD5423 inhalation I-neb |
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| 4 | Experimental | AZD5423 oral |
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| 5 | Experimental | AZD5423 inhalation Turbuhaler |
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| 6 | Experimental | AZD5423, New Dry Powder Inhaler |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD5423 | Drug | solution for injection, administered as intravenous infusion Corr to total dose of 250 µg AZD5423 |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of AZD5423 delivered by the new dry powder inhaler in terms of: Fpulmonary | Blood samples taken pre-dose and at10, 20 and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36, 48 and 96 hours post dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of AZD5423 following i.v administration in terms of : AUC, AUC(0-t), Fpo, Finhalation total, Fpulmonary, Foral, Frel, Frel Cmax, Cmax, Cmax(tmax), t½λz, MAT, MRT, Vz and Vss | Blood samples taken pre-dose and at 5, 10, 25, 30, 35 and 45 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36, 48, 72 and 96 hours post dose. | |
| Pharmacokinetics of AZD5423 following oral administration in terms of : AUC, AUC(0-t), Fpo, Finhalation total, Fpulmonary, Foral, Frel, Frel Cmax, Cmax, Cmax(tmax), t½λz, MAT, MRT, Vz and Vss |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carin Jorup, MD | AstraZeneca R&D, Molndal Sweden | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London | UK | United Kingdom |
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| Label | URL |
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| CSR Synopsis | View source |
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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 |
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| AZD5423 | Drug | nebuliser suspension, inhaled via I-neb, corr to approximately 300 µg lung deposited dose AZD5423 |
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| AZD5423 | Drug | nebuliser suspension to be administered orally, corr to a total dose of 1200 µg AZD5423 |
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| AZD5423 | Drug | dry powder inhaled via Turbuhaler, corr to approximately 200 µg lung deposited dose AZD5423 |
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| AZD5423 | Drug | dry powder inhaled via New Dry Powder Inhaler, corr to approximately 200 µg lung deposited dose AZD5423 |
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| Blood samples taken pre-dose and at10, 20 and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36 and 48 hours post dose. |
| Pharmacokinetics of AZD5423 following oral inhalation by Spira, I-neb, Turbuhaler and New Dry Powder Inhaler in terms of : AUC, AUC(0-t), Fpo, Finhalation total, Fpulmonary, Foral, Frel, Frel Cmax, Cmax, Cmax(tmax), t½λz, MAT, MRT, Vz and Vss | Blood samples taken pre-dose and at10, 20 and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36, 48 and 96 hours post dose. |
| Safety profile in terms of adverse events, ECG, heart rate, blood pressure, pulse rate, body temperature, physical examination, spirometry, haematology, clinical chemistry and urinalysis. | No formal statistical tests will be performed. | Screening to 28 days post dose. |