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This Study evaluates the possible drug interaction between FosD and verapamil when taken together.
An Open-label, Single-Centre Study to Assess the Pharmacokinetics of R406 in Healthy Volunteers when Fostamatinib Disodium 150 mg is Administered Alone and in Combination with Verapamil.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 | Experimental |
| |
| Period 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOSTAMATIN | Drug | Oral tablets - single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To determine plasma PK parameters of R406 when FosD is given in combination with verapamil (including but not limited to: AUC, tmax, Cmax and terminal elimination half life (t1/2)) of FosD. | Daily during Treatment Period 1 (FosD alone) and Treatment Period 2 (FosD plus verapamil) until 96 hours post each single dose of FosD |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate safety and tolerability of FosD when given in combination with verapamil: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs. | Screening, throughout both treatment periods, and follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Layton, MD | AstraZeneca | Study Director |
| Carlos Prendes, MD | Quintiles, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Recruiting Site | Overland Park | Kansas | United States |
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| ID | Term |
|---|---|
| D014700 | Verapamil |
| ID | Term |
|---|---|
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Verapamil |
| Drug |
Oral tablets - administered 3 times daily over 4 days |
|