Healthy Volunteer
Conditions
Brief summary
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).
Interventions
DRUG[14C]-GDC-0980
100 uCi of \[14C\]-GDC-0980 in total dose of 10 mg GDC-0980
Sponsors
Genentech, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Medically healthy as determined by the absence of clinically significant findings in the medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator * Female subjects of non-childbearing potential, as defined as either: postmenopausal and without recent history of menorrhea as documented either by physician note or confirmed by serum follicle-stimulating hormone level consistent with postmenopausal status, or surgically sterile * BMI range within 18.5 to 29.9 kg/m2, inclusive * Negative test for selected drugs of abuse at Screening and at Check-in * Negative hepatitis panel (including hepatitis B surface antigen \[HBsAg\], hepatitis C virus antibody \[anti-HCV\] and negative HIV antibody screens * Minimum of 1 to 2 bowel movements per day
Exclusion criteria
* Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder * History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance * History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs * History or presence of inflammatory diseases, including those with small or large intestine inflammation such as Crohn's disease or ulcerative colitis, which required immunosuppressants * Use of potent proton-pump inhibitors such as omeprazole, lansoprazole, dexlansoprazole, esomeprazole, pantoprazole, and rabeprazole * History of Gilbert's Syndrome * History of diabetes mellitus and/or elevated fasting glucose at baseline * History or presence of an abnormal ECG * History of alcoholism or drug addiction within 1 year prior to Check-in * Participation in more than one other radiolabeled investigational study drug trial within 12 months prior to Check-in. The previous radiolabeled study drug must have been received more than 6 months prior to Check-in for this study and the total exposure from this study and the previous study will be within the recommended levels considered safe * Exposure to significant radiation 12 months prior to Check-in * Use of any tobacco-containing or nicotine-containing products within 3 months/approximately 90 days prior to Check-in or positive urine screening for cotinine * Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives or 30 days, whichever is longer, prior to Check-in * Use of any prescription medications/products within 14 days prior to Check-in, unless deemed acceptable by the Investigator * Use of any over-the-counter (OTC), non-prescription preparations within 7 days prior to Check-in * Use of alcohol-, grapefruit-, or caffeine-containing foods or beverages within 72 hours * Poor peripheral venous access * Donation of blood from 30 days prior to Screening or of plasma from 2 weeks prior to Screening * Receipt of blood products within 2 months prior to Check-in * Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent volume of distribution | 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 | up to approximately 5 weeks |
| Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent terminal elimination half-life (t1/2) | up to approximately 5 weeks |
| Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent terminal phase elimination rate constant | up to approximately 5 weeks |
| Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent total clearance | up to approximately 5 weeks |
| Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: maximum observed concentration (Cmax) | up to approximately 5 weeks |
| Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: time to maximum concentration (tmax) | 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) | up to approximately 5 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic based on the urine radioactivity concentrations: renal clearance | up to approximately 5 weeks |
| Pharmacokinetic based on the urine radioactivity concentrations: percent excreted in urine | up to approximately 5 weeks |
| Pharmacokinetic parameters for the metabolites of [14C]-GDC-0980 calculated based on plasma, urine, and fecal concentration levels. | up to approximately 5 weeks |
| Pharmacokinetic based on the urine radioactivity concentrations: amount of drug excreted in the urine over sampling interval | up to approximately 5 weeks |
Countries
United States
Outcome results
None listed