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Study in Healthy Males to Compare the White and Blue Formulations of AZD6244.
A Phase I, Single-center, Randomized, Open-label, Crossover Study to Compare the White (Current Phase II) and Blue (Planned Phase III) Capsule Formulations of AZD6244 Hyd-Sulfate in Healthy Male Subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD6244 white capsule | Experimental | 75mg AZD6244 white (current Phase II) capsule |
|
| AZD6244 blue capsule | Experimental | 75mg AZD6244 blue (planned Phase III) capsule |
|
| AZD6244 solution | Experimental | 35mg AZD6244 oral solution |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD6244 Dosing Period 1 | Drug | Treatment A, B, or C depending on randomization assignment |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC for AZD6244 administered as a single dose of white (current Phase II) capsule formulation | Measured at appropriate time-points until end of treatment peiod, approximately 24 days | |
| Cmax for AZD6244 administered as a ingle dose of white (current Phase II) capsule formulation | Measured at appropriate time-points until end of treatment peiod, approximately 24 days | |
| AUC for AZD6244 administered as a single dose of blue (planned Phase III) capsule formulation | Measured at appropriate time-points until end of treatment peiod, approximately 24 days | |
| Cmax for AZD6244 administered as a single dose of blue (planned Phase III) capsule formulation | Measured at appropriate time-points until end of treatment peiod, approximately 24 days |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of adverse events | Measured throughout the study and for a7 days after the last dose, approximately 29 days | |
| AUC for AZD6244 administered as a single dose of oral solution formulation | Measured at appropriate time-points until end of treatment peiod, approximately 24 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian Smith, MEDICAL SCIENCE DIRECTOR | AstraZeneca | Study Director |
| Eleanor Lisbon, MD | Quintiles, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reseatch Site | Overland Park | Kansas | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28985960 | Derived | Tomkinson H, McBride E, Martin P, Lisbon E, Dymond AW, Cantarini M, So K, Holt D. Comparison of the Pharmacokinetics of the Phase II and Phase III Capsule Formulations of Selumetinib and the Effects of Food on Exposure: Results From Two Randomized Crossover Trials in Healthy Male Subjects. Clin Ther. 2017 Nov;39(11):2260-2275.e1. doi: 10.1016/j.clinthera.2017.08.022. Epub 2017 Oct 4. |
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| AZD6244 Dosing Period 2 | Drug | Treatment A, B, or C depending on randomization assignment |
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| AZD6244 Dosing Period 3 | Drug | Treatment A, B, or C depending on randomization assignment |
|
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| AZD6244 Dosing Period 4 | Drug | Treatment B |
|
|
| Cmax for AZD6244 administered as a single dose of oral solution formulation | Measured at appropriate time-points until end of treatment peiod, approximately 24 days |
| ID | Term |
|---|---|
| C517975 | AZD 6244 |
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