This Phase 1, open-label, randomized, 4-period crossover study is designed to determine the relative bioavailability of GDC-0941 administered as a single dose of the market image formulation at 3 different hardnesses (hardness 1, 2, and 3) and as a single dose of the Phase 2 formulation to healthy male and female volunteers. Participants will be randomly assigned to 4 possible treatment sequences, each comprising 4 periods (1 per formulation), and GDC-0941 will be administered based on the assigned sequence. The study is expected to last 8 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Single dose market image tablet of hardness 1
Single dose market image tablet of hardness 2
Single dose market image tablet of hardness 3
Single dose Phase 2 tablet formulation
Unnamed facility
Madison, Wisconsin, United States
Area under the concentration-time curve (AUC) of plasma GDC-0941
Time frame: 25 Days
Maximum plasma concentration (Cmax) of GDC-0941
Time frame: 25 Days
Relative bioavailability (Frel) according to the model independent approach
Time frame: 25 days
Incidence of adverse events
Time frame: 25 days
Electrocardiogram (ECG)
Time frame: 25 days
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