Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-0980 Following Single Oral Dose Administration in Healthy Postmenopausal Female Subjects
Phase 1
Completed
- Conditions
- Healthy Volunteer
- Interventions
- Drug: [14C]-GDC-0980
- Registration Number
- NCT01487239
- Lead Sponsor
- Genentech, Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 4
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A [14C]-GDC-0980 \[14C\]-GDC-0980 administered as a 10-mg oral dose
- Primary Outcome Measures
Name Time Method 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: apparent total clearance 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: area under the concentration-time curve from Hour 0 to the last measurable concentration (AUC0-t) 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 phase elimination rate constant up to approximately 5 weeks Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent volume of distribution up to approximately 5 weeks
- Secondary Outcome Measures
Name Time Method 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 Pharmacokinetic based on the urine radioactivity concentrations: renal clearance up to approximately 5 weeks