This 4-part study will assess the effect of formulation, food, and active pharmaceutical ingredient (API) lot on the pharmacokinetics of GDC-0032 in healthy volunteers. Part 1 is an open-label, 3-period, 6-sequence study, and Parts 2, 3, and 4 are open-label 2-period crossover studies. Participants will receive single doses of GDC-0032 capsule or tablet formulation, in the fasted or fed state.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
76
Participants will receive 2 mg or 3 mg Phase III tablet after 10 hour fasting from food.
Participants will receive 3 mg Tablet A or Tablet B formulation after 10 hour fasting from food.
Participants will receive 3 mg GDC-0032 capsule formulation after 10 hour fasting from food.
Covance Research Unit - Dallas
Dallas, Texas, United States
Area Under the Concentration-Time Curve From Hour 0 to the Last Measurable Concentration (AUC0-t)
Time frame: Pre-dose (Hour 0), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 168, 192 hour post-dose
Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-infinity)
Time frame: Pre-dose (Hour 0), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 168, 192 hour post-dose
Maximum Plasma Concentration (Cmax)
Time frame: Pre-dose (Hour 0), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 168, 192 hour postdose
Time to Maximum Plasma Concentration (tmax)
Time frame: Pre-dose (Hour 0), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 168, 192 hour post-dose
Apparent Terminal Elimination Rate Constant
Time frame: Pre-dose (Hour 0), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 168, 192 hour post-dose
Apparent Terminal Elimination Constant (t1/2)
Time frame: Pre-dose (Hour 0), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 168, 192 hour post-dose
Apparent Total Clearance (CL/F)
Time frame: Pre-dose (Hour 0), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 168, 192 hour post-dose
Apparent Volume of Distribution (Vz/F)
Time frame: Pre-dose (Hour 0), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 168, 192 hour post-dose
Percentage of Participants With Adverse Events
Time frame: From Baseline up to approximately 15 weeks
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