A Pharmacokinetics Study of Radioactive-Labeled GDC-0973 in Healthy Male Volunteers
- Registration Number
- NCT01711762
- Lead Sponsor
- Genentech, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GDC-0973 Single Arm GDC-0973 -
- Primary Outcome Measures
Name Time Method Route of elimination of [14C]-GDC-0973 approximately 8 weeks Pharmacokinetics: maximum observed concentration (Cmax) approximately 8 weeks Pharmacokinetics: area under the concentration-time curve approximately 8 weeks Pharmacokinetics: apparent terminal elimination phase rate constant 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 Pharmacokinetics: amount total radioactivity in whole blood/urine/feces approximately 8 weeks Pharmacokinetics: time to maximum concentration (tmax) approximately 8 weeks
- Secondary Outcome Measures
Name Time Method Pharmacokinetics: quantification of GDC-0973-related metabolites in plasma, urine and fecal homogenates approximately 8 weeks Pharmacokinetics: plasma concentration of GDC-0973 approximately 8 weeks Safety: incidence of adverse events approximately 8 weeks