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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No.: 2009-012114-43 |
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The study was terminated due to results in another study (NCT00878501).
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The study will investigate how a new formulation of the study drug is absorbed, metabolised and distributed through the body, as well as its safety and tolerability in higher doses when given as single and multiple doses and as a single dose in the presence and absence of naproxen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: A | Experimental | AZD1386 |
|
| Part A: B | Experimental | Placebo for AZD1386 |
|
| Part B: A | Experimental | Naproxen |
|
| Part B: B | Experimental | Placebo for Naproxen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1386 | Drug | Single ascending and multiple (twice daily) oral doses, capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety variables (adverse events, vital signs, ECG, safety lab) | Assessments performed at frequent timepoints (predose then ranging from 15 minutes to every 12 hours) on Days -1 to Day 3 (Part A: treatment period 1 and Part B) or Day-1 to Day 9 (Part A: treatment period 2) and at follow-up 4-14 days after discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the pharmacokinetics of AZD1386 in plasma | Assessments performed at frequent timepoints (predose then ranging from 15 minutes to every 12 hours) on Days -1 to Day 3 (Part A: treatment period 1 and Part B) or Day-1 to Day 9 (Part A: treatment period 2). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Leff | AstraZeneca Pharmaceuticals, Wilmington, UK | Study Director |
| Dr. Tania Hugo | PAREXEL Early Phase Clinical Unit, London UK. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Harrow | United Kingdom |
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| ID | Term |
|---|---|
| C574562 | AZD1386 |
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Placebo for AZD1386 |
| Drug |
Single ascending and multiple (twice daily) oral doses, capsule |
|
| Naproxen | Drug | Tablet, single oral dose, 500mg |
|
| Placebo for Naproxen | Drug | Tablet, single oral dose |
|
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |