A Pharmacokinetics Study of Radioactive-Labeled GDC-0973 in Healthy Male Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-0973 Following Single Oral Dose Administration in Healthy Male Subjects

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: GDC-0973


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GDC-0973 Single Arm<br> | Drug: GDC-0973<br>* Single oral dose of [14C]-GDC-0973<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |