A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-0973 Following Single Oral Dose Administration in Healthy Male Subjects
Overview
- Phase
- Phase 1
- Intervention
- GDC-0973
- Conditions
- Healthy Volunteer
- Sponsor
- Genentech, Inc.
- Enrollment
- 6
- Primary Endpoint
- Pharmacokinetics: maximum observed concentration (Cmax)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
GDC-0973 Single Arm
Intervention: GDC-0973
Outcomes
Primary Outcomes
Pharmacokinetics: maximum observed concentration (Cmax)
Time Frame: approximately 8 weeks
Route of elimination of [14C]-GDC-0973
Time Frame: approximately 8 weeks
Pharmacokinetics: area under the concentration-time curve
Time Frame: approximately 8 weeks
Pharmacokinetics: apparent terminal elimination phase rate constant
Time Frame: approximately 8 weeks
Pharmacokinetics: apparent terminal elimination phase half-life
Time Frame: approximately 8 weeks
Pharmacokinetics: apparent total clearance
Time Frame: approximately 8 weeks
Pharmacokinetics: apparent volume of distribution
Time Frame: approximately 8 weeks
Pharmacokinetics: amount total radioactivity in whole blood/urine/feces
Time Frame: approximately 8 weeks
Pharmacokinetics: time to maximum concentration (tmax)
Time Frame: approximately 8 weeks
Secondary Outcomes
- 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)