Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD6244 Dosing · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 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 |
| Name | Type | Description |
|---|---|---|
| AZD6244 Dosing Period 1 | DRUG | Treatment A, B, or C depending on randomization assignment |
| AZD6244 Dosing Period 2 | DRUG | Treatment A, B, or C depending on randomization assignment |
| AZD6244 Dosing Period 3 | DRUG | Treatment A, B, or C depending on randomization assignment |
| AZD6244 Dosing Period 4 | DRUG | Treatment B |
Inclusion Criteria: * Healthy male volunteers aged 18 to 55 BMI between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg, inclusive Calculated creatinine clearance (CRCL) greater than 50 mL/min usin gthe Cockcroft-Gault formula Exclusion Criteria: * History or presence o...
AZD6244 Dosing refers to the dosing comparison study of AZD6244, a small molecule developed by AstraZeneca PLC. The Phase 1 trial compared the then-current Phase II capsule formulation with the planned Phase III capsule formulation in healthy male volunteers. It is also known as AZD6244 Dosing Period 1.
AZD6244 Dosing is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca sponsored the Phase 1 formulation comparison study of the drug.
AZD6244 Dosing is in Phase 1 development. The single listed trial, NCT01635023, is a completed Phase 1 study, and no active trials are ongoing. The drug is investigational and has not been approved.
AZD6244 Dosing was studied in one clinical trial, NCT01635023, titled a randomized, open label study to compare the current Phase II and planned Phase III capsule formulation of AZD6244. The Phase 1 trial enrolled 27 healthy male volunteers in the United States and is completed.
Yes, AZD6244 Dosing is also known as AZD6244 Dosing Period 1. Both names refer to the same AstraZeneca small molecule formulation comparison program.
Yes, the AZD6244 Dosing trial NCT01635023 was randomized and controlled, though it was open label rather than double blind. It enrolled 27 healthy male volunteers aged 18 years and older in the United States and is completed.