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Study to Assess the Absorption, Metabolism and Excretion of [14C]AZD8931 after a Single-Dose Oral Administration
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD8931 | Experimental | [14C] AZD8931 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C] AZD8931 | Drug | Single 160 mg oral dose administered on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the absorption, distribution, metabolism and excretion of AZD931 in human subjects | Multiple blood , urine and faecal samples from pre-dose until 240 hours post last dose | |
| To investigate the pharmacokinetic variable of AZD8931 in plasma | Multiple PK blood samples from pre-dose until 240 hours post last dose |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the safety and tolerability of AZD8931 given orally | Frequent safety measurements during the study from screening period to follow-up | |
| To investigate the AZD8931 metabolites variables in plasma | Multiple PK blood samples from pre-dose until 240 hours post last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darren Wilbraham, MBBS, DCPSA | Quintiles Drug Research Unit at Guy's Hospital | Principal Investigator |
| Mary Stuart | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25007130 | Derived | Ballard P, Swaisland HC, Malone MD, Sarda S, Ghiorghiu S, Wilbraham D. Metabolic disposition of AZD8931, an oral equipotent inhibitor of EGFR, HER2 and HER3 signalling, in rat, dog and man. Xenobiotica. 2014 Dec;44(12):1083-98. doi: 10.3109/00498254.2014.938257. Epub 2014 Jul 9. |
| Label | URL |
|---|---|
| Clinical\_Study\_Protocol\_redacted | View source |
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| ID | Term |
|---|---|
| C548875 | AZD 8931 |
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