Healthy Volunteer
Conditions
Brief summary
This open-label, non-randomized study will assess the absorption, metabolism, and excretion of radioactive-labeled \[14C\]-GDC-0973 in healthy male volunteers. Volunteers will receive a single dose of \[14C\]-GDC-0973.
Interventions
DRUGGDC-0973
Single oral dose of \[14C\]-GDC-0973
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index (BMI) between 18.5 and 29.9 kg/m2, inclusive * No clinically significant findings from medical history, 12-lead ECG, and vital signs and laboratory evaluations * Negative test for selected drugs of abuse * No infection with hepatitis B, hepatitis C, human immunodeficiency virus (HIV) * Sterile or agree to use an adequate contraception method * Historically able to produce a minimum of 1 bowel movement 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 unless approved by the Investigator * History of stomach or intestinal surgery or resection (including a cholecystectomy) that would potentially alter absorption and/or excretion of orally administered drugs except that appendectomy and/or 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 Check-in * Participation in more than one other radiolabeled investigational study drug trial within 12 months prior to Check-in * Exposure to significant radiation within 12 months prior to Check-in study drug occurred within 5 half-lives or 30 days, whichever is longer, prior to Check-in * Use of any tobacco-containing or nicotine-containing products within 6 months prior to Check-in * Participation in any other investigational study drug or biologic agent 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: amount total radioactivity in whole blood/urine/feces | approximately 8 weeks |
| Pharmacokinetics: apparent terminal elimination phase half-life | approximately 8 weeks |
| Pharmacokinetics: apparent total clearance | approximately 8 weeks |
| Pharmacokinetics: apparent volume of distribution | approximately 8 weeks |
| Route of elimination of [14C]-GDC-0973 | approximately 8 weeks |
| Pharmacokinetics: maximum observed concentration (Cmax) | approximately 8 weeks |
| Pharmacokinetics: time to maximum concentration (tmax) | approximately 8 weeks |
| Pharmacokinetics: area under the concentration-time curve | approximately 8 weeks |
| Pharmacokinetics: apparent terminal elimination phase rate constant | approximately 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: plasma concentration of GDC-0973 | approximately 8 weeks |
| Safety: incidence of adverse events | approximately 8 weeks |
| Pharmacokinetics: quantification of GDC-0973-related metabolites in plasma, urine and fecal homogenates | approximately 8 weeks |
Countries
United States
Outcome results
None listed