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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number 2012-002901-23 |
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The purpose of this study is to look at drug levels of AZD8683 in blood when the drug is administered in different ways - orally, intravenously or inhaled (with two different devices), to healthy subjects
A Phase I, Single-centre, Open-label, Partly Randomised, Cross-over Single Dose Study in Healthy Volunteers to Evaluate the Absolute Pulmonary Bioavailability of AZD8683 when Administered Inhaled via a New Dry Powder Inhaler and via Turbuhaler™
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD8683 iv |
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| 2 | Experimental | AZD8683 oral |
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| 3 | Experimental | AZD8683 inhalation New Dry Powder Inhaler |
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| 4 | Experimental | AZD8683 inhalation Turbuhaler™ |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD8683 | Drug | Solution for injection, administered as intravenous infusion Total dose of 100µg AZD8683 |
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| Measure | Description | Time Frame |
|---|---|---|
| Absolute pulmonary bioavailability of AZD8683 delivered by the new dry powder inhaler in terms of: Fpulmonary | Blood samples taken pre-dose and at 5, 15 and 30 minutes and 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute pulmonary bioavailability of AZD8683 delivered by the Turbuhaler™ in terms of: Fpulmonary | Blood samples taken pre-dose and at 5, 15 and 30 minutes and 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post dose. | |
| Pharmacokinetics of AZD8683 following administration in terms of oral inhalation by Turbuhaler™ and New Dry Powder Inhaler in terms of: Finhalation total, FrelAUC, Frel Cmax and Foral |
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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 |
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| AZD8683 | Drug | Solution to be administered orally Total dose of 950 µg AZD8683 |
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| AZD8683 | Drug | Dry powder inhaled via New Dry Powder Inhaler, 540 µg delivered dose AZD8683 |
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| AZD8683 | Drug | Dry powder inhaled via Turbuhaler™, 600 µg delivered dose AZD8683 |
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| Blood samples taken pre-dose and at 5, 15 and 30 minutes and 1, 2, 4, 8, 12,24, 36, 48, 72, 96, 120 and 144 hours post dose. |
| Pharmacokinetics of AZD8683 following oral administration in terms of: Fpo | Blood samples taken pre-dose and at 5, 15 and 30 minutes and 1, 2, 4, 8, 12 ,24, 36, and 48 hours post dose. |
| Pharmacokinetics of AZD8683 following oral administration and oral inhalation by Turbuhaler™ and New Dry Powder inhaler in terms of : AUC, AUC(0-t), Cmax, tmax, t½λz, MRT and MAT. | Blood samples taken pre-dose and at 5, 15 and 30 minutes and 1, 2, 4, 8, 12,24, 36, 48, 72 96, 120 and 144 hours post dose. |
| Pharmacokinetics of AZD8683 following i.v. administration in terms of: CL, Vz, and Vss | Blood samples taken pre-dose and at 5, 15, 20, 25 and 40 minutes and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 144 hours post dose. |
| Safety profile in terms of adverse events, ECG, heart rate, blood pressure, body temperature, physical examination, spirometry, haematology, clinical chemistry and urinalysis. | No formal statistical tests will be performed. | Screening to 4 weeks after last dose. |