Healthy Volunteer
Conditions
Brief summary
This study will be an open-label, non-randomized, absorption, metabolism, and excretion study of \[14C\]-GDC 0941 administered as an oral dose to 6 healthy male subjects following at least a 10-hour fast from food (not including water).
Interventions
DRUGGDC-0941
Single oral dose\\n \\n\\n\\n\\n
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Within BMI range 18.5 to 29.9 kg/m2, inclusive * In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs * Clinical laboratory evaluations within the reference range for the test laboratory * 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 * Subjects will either be sterile or agree to use an approved form of contraception from Check-in until 45 days following Study Completion/ET * Agree not to donate sperm from Screening throughout the study period and for at least 3 months (90 days) after the last dose of study drug * A 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 (except that appendectomy and hernia repair will be allowed) * 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 within 12 months prior to Check-in * Use of any tobacco-containing or nicotine-containing products within 6 months prior to Check-in or positive urine drug screen 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 (including vitamins, minerals, and phytotherapeutic/herbal/plant derived preparations) within 7 days prior to Check-in * Use of alcohol-, grapefruit-, or caffeine-containing foods or beverages within 72 hours prior to Check-in, unless deemed acceptable by the Investigator * 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 property based on the plasma concentrations of total radioactivity and GDC-0941: time to maximum concentration | up to approximately 6 weeks or early study discontinuation |
| Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: area under the concentration-time curve from Hour 0 to the last measurable concentration | up to approximately 6 weeks or early study discontinuation |
| Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: maximum observed concentration | up to approximately 6 weeks or early study discontinuation |
| Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: apparent terminal elimination half-life | up to approximately 6 weeks or early study discontinuation |
| Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: apparent terminal phase elimination rate constant | up to approximately 6 weeks or early study discontinuation |
| Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: apparent total clearance | up to approximately 6 weeks or early study discontinuation |
| Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: apparent volume of distribution | up to approximately 6 weeks or early study discontinuation |
| Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: area under the concentration-time curve extrapolated to infinity | up to approximately 6 weeks or early study discontinuation |
Secondary
| Measure | Time frame |
|---|---|
| Percent excreted in feces | up to approximately 6 weeks or early study discontinuation |
| Amount of drug excreted in the feces over the sampling interval | up to approximately 6 weeks or early study discontinuation |
Countries
United States
Outcome results
None listed