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| ID | Type | Description | Link |
|---|---|---|---|
| QBR112696 |
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Study in healthy males to assess bioavailability of single fostamatinib with iv micro tracer dose.
A Study to Assess the Absolute Bioavailability of a Single Oral Dose of Fostamatinib with Respect to an Intravenous Micro Tracer Dose of [14C] R406 in Healthy Male Volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fostamatinib 50 mg tablet | Experimental |
| |
| Fostamatinib 100 μg [14C] R406 intravenous micro tracer dose | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fostamatinib | Drug | Fostamatinib 50 mg tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The percent of absolute bioavailability (F) of R406 after oral administration of fostamatinib. | Up to 96 hours post dose | |
| Total radioactivity of [14C] R406 after an intravenous infusion of [14C]R406 in terms of AUC, AUC(0-t), Cmax, t1/2λz, MRT, CL, Vz. | AUC-Area under the plasma concentration time curve; AUC(0-t)-Area under plasma concentration time curve from zero to time of the last measurable concentration; Cmax - max plasma concentration; t½ λz-Terminal half-life; MRT- Mean residence time; CL - Total body clearance; Vz - Volume of distribution during the terminal phase | Up to 96 hours post dose |
| Pharmacokinetic (PK) profile of a single oral dose of fostamatinib and a radiolabelled intravenous micro tracer dose of [14C] R406. | PK Parameters: AUC, AUC (0-t), Cmax, t½ λz and MRT | 0, 30min, 1h, 1h 30min, 1h 45min, 1h 50min, 1h 55min, 2, 2h 5min, 2h 10min, 2h 15min, 2h30min, 3, 3h 30min, 5h30min, 9h, 12h, 18h, 24h, 30h, 48h, 72h, 96h post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events. | Up to Day 12 | |
| Safety profile in terms of vital signs (blood pressure and pulse), clinical laboratory tests, ECGs and physical examination findings. | Up to Day 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Layton, MD | AstraZeneca, Alderley Park | Study Director |
| Sharan Sidhu, MB CHB, BAO, MRCS | Quotient Clinical Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruddington | Nottingham | United Kingdom |
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| ID | Term |
|---|---|
| C523665 | fostamatinib |
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| Fostamatinib |
| Drug |
Fostamatinib 100 μg [14C] R406 intravenous micro tracer dose |
|