This 2-arm, open-label, non-randomized study will investigate the absolute bioavailability, pharmacokinetics, mass balance, and routes of elimination of GDC-0032 as well as its safety in healthy volunteers. Patients will receive either a single oral dose of GDC-0032 followed by a 14C-labeled IV dose of GDC-0032 or a single oral dose of 14C-labelled GDC-0032.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
15
Unnamed facility
Madison, Wisconsin, United States
Bioavailability: Absolute bioavailability of GDC-0032 (Area under the concentration-time curve [AUC])
Time frame: Days 1 to 11
Elimination & PK: Amount of drug excreted in urine/feces over the sampling interval
Time frame: Days 1 to 22
Elimination & PK: Maximum concentration (Cmax) of GDC-0032
Time frame: Days 1 to 22
Elimination & PK: Area under the concentration-time curve (AUC)
Time frame: Days 1 to 22
Elimination & PK: Total radioactivity concentrations in whole blood, plasma, urine, and feces.
Time frame: Days 1 to 22
Elimination & PK: Metabolite identification in plasma, urine, & feces
Time frame: Days 1 to 22
Safety: Incidence of adverse events
Time frame: 38 to 49 days
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