Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A study in Healthy Volunteers to Compare the Amount of R406 in Blood When Given Different Formulations of Fostamatinib.
An Open-label, Single-center, Randomized, 4-way Crossover Study to Assess the Bioequivalence of R406 in Healthy Volunteers when 100 and 150mg of Fostamatinib are Administered as the 13% Drug-loaded Tablet Versus the 38% Drug-loaded Tablet.
Treatment sequences will be determined using two 2-2 crossover designs in sequence, 1 for treatments A and B, and 1 for treatments C and D. The order of the designs containing AB/BA and CD/DC within the overall design, as well as the order of treatments within each design, will be randomized. This gives a total of 8 possible treatment sequences as follows: ABCD, ABDC, BACD, BADC, CDAB, CDBA, DCAB, DCBA.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | 100mg MCC-based 13% drug-loaded tablets |
|
| Treatment B | Experimental | 100mg mannitol-based 38% drug-loaded tablets |
|
| Treatment C | Experimental | 150mg MCC-based 13% drug-loaded tablets |
|
| Treatment D | Experimental | 150mg mannitol-based 38% drug-loaded tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCC-based 13% drug loaded tablets | Drug | 50mg tablets, dosed as 2 tablets (100mg total) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence of R406 when fostamatinib is administered as two 50mg MCC-based 13% drug-loaded tablets versus one 100mg mannitol-based 38% drug-loaded tablet | Measured at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdose | |
| Bioequivalence of R406 when fostamatinib is administered as three 50mg MCC-based 13% drug-loaded tablets versus one 150mg mannitol-based 38% drug-loaded tablet | Measured at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| AUC for mannitol-based 38% drug-loaded tablets and MCC-based 13% drug-loaded tablets | Measured at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdose | |
| Cmax for mannitol-based 38% drug-loaded tablets and MCC-based 13% drug-loaded tablets |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chris O'Brien, MEDICAL SCIENCE DIRECTOR | AstraZeneca | Study Director |
| David Mathews, MD | Quintiles, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Overland Park | Kansas | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Mannitol-based 38% drug-loaded tablet |
| Drug |
One 100mg tablet |
|
| MCC-based 13% drug loaded tablets | Drug | 3 tablets (150mg total) |
|
| Mannitol-based 38% drug-loaded tablet | Drug | One 150 mg tablet |
|
| Measured at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdoses |
| Frequency of adverse events | Measured throughout the study and 3 -5 days after discharge from Period 4, approximately 45 days |
| Severity of adverse events | Measured throughout the study and 3 -5 days after discharge from Period 4, approximately 45 days |