This study will be an open-label, non-randomized, absorption, metabolism, and excretion study of \[14C\]-GDC-0980 administered as a 10-mg oral dose to 6 healthy postmenopausal and/or surgically sterile female subjects following at least a 10-hour fast from food (not including water).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
100 uCi of \[14C\]-GDC-0980 in total dose of 10 mg GDC-0980
Unnamed facility
Madison, Wisconsin, United States
Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: maximum observed concentration (Cmax)
Time frame: up to approximately 5 weeks
Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: time to maximum concentration (tmax)
Time frame: up to approximately 5 weeks
Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: area under the concentration-time curve from Hour 0 to the last measurable concentration (AUC0-t)
Time frame: up to approximately 5 weeks
Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: area under the concentration-time curve extrapolated to infinity
Time frame: up to approximately 5 weeks
Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent terminal elimination half-life (t1/2)
Time frame: up to approximately 5 weeks
Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent terminal phase elimination rate constant
Time frame: up to approximately 5 weeks
Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent total clearance
Time frame: up to approximately 5 weeks
Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent volume of distribution
Time frame: up to approximately 5 weeks
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Pharmacokinetic based on the urine radioactivity concentrations: amount of drug excreted in the urine over sampling interval
Time frame: up to approximately 5 weeks
Pharmacokinetic based on the urine radioactivity concentrations: renal clearance
Time frame: up to approximately 5 weeks
Pharmacokinetic based on the urine radioactivity concentrations: percent excreted in urine
Time frame: up to approximately 5 weeks
Pharmacokinetic parameters for the metabolites of [14C]-GDC-0980 calculated based on plasma, urine, and fecal concentration levels.
Time frame: up to approximately 5 weeks