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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
27
Treatment A, B, or C depending on randomization assignment
Treatment A, B, or C depending on randomization assignment
Treatment A, B, or C depending on randomization assignment
Reseatch Site
Overland Park, Kansas, United States
AUC for AZD6244 administered as a single dose of white (current Phase II) capsule formulation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Measured at appropriate time-points until end of treatment peiod, approximately 24 days
Frequency and severity of adverse events
Time frame: 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
Time frame: Measured at appropriate time-points until end of treatment peiod, approximately 24 days
Cmax for AZD6244 administered as a single dose of oral solution formulation
Time frame: Measured at appropriate time-points until end of treatment peiod, approximately 24 days
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Treatment B