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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No.: 2007-005903-16 |
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This study is being performed in order to learn more about a new drug (possible as treatment for people with Alzheimer's Disease and other conditions with cognitive dysfunction (memory and attention problems)) and how it is handled by the body by giving the drug to healthy volunteers with different genotypes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD3480 iv | Experimental | Single iv infusion AZD3480 |
|
| Oral [14C] AZD3480 | Experimental | Single oral dose [14C]AZD3480 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD3480 | Drug | Iv single dose, 4-hour infusion of 25 mg |
| |
| AZD3480 |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery (% dose) of radioactivity retrieved in urine and faeces Total radioactivity in blood and plasma, AUC, Cmax , tmax, t1/2 and blood/plasma ratio. | Urine and faeces collection for at least 168 hours (up to 2 weeks)9 (blood) and 17 (plasma) samples during 48 and 72 hours. | |
| Plasma and urine concentration (AUC, Cmax, tmax, t1/2, F, CL, CLR, fe, Ae, and Vss) | 19 and 18 blood samples during 72 and 96 hours after iv (Visit 2) and po dosing (Visit 3) respectively. Urine collection for 72 hours and 168 hours (up to 2 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| identity of major metabolites in plasma and excreta | 4 blood samples during 8 hours.Urine and faeces collection for at least 168 hours (up to 2 weeks). | |
| Adverse Events, vital signs (supine blood pressure and pulse rate), ECG, hematology, clinical chemistry and urinalysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Björn Paulsson, MD, PhD | AstraZeneca Södertälje, Sweden | Study Director |
| Tim Mant, Prof | Quintiles Drug Research Unit @ Guy´s Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Macclesfield | Cheshire | United Kingdom |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C490152 | ispronicline |
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| Drug |
Oral solution single dose of 50 mg |
|
| From enrollment to follow-up |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |