A Bioavailability and Pharmacokinetic Study of GDC-0032 in Healthy Volunteers

Study Overview
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Brief Summary
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This 2-arm, open-label, non-randomized study will investigate the absolute bioavailability, pharmacokinetics, mass balance, and routes of elimination of GDC-0032 as well as its safety in healthy volunteers. Patients will receive either a single oral dose of GDC-0032 followed by a 14C-labeled IV dose of GDC-0032 or a single oral dose of 14C-labelled GDC-0032.

Official Title
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A PHASE 1 STUDY TO INVESTIGATE THE ABSOLUTE BIOAVAILABILITY OF GDC-0032 AND THE ABSORPTION, METABOLISM, AND EXCRETION OF [14C]-GDC-0032 IN HEALTHY MALE SUBJECTS

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: GDC-0032
* Drug: GDC-0032


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body Mass Index (BMI) 18 to 32 kg/m2, inclusive; Healthy, as judged by physician from medical history, 12-lead ECG, vital signs, and clinical laboratory evaluations; Agree to use effective contraceptive methods as defined by protocol; Negative hepatitis panel and HIV screen; Sufficient bowel movements (minimum of 1 per day). Exclusion Criteria: History or clinical manifestation of: any major medical disorders; any food/drug/substance allergies; History of stomach or intestinal surgery or resection except for appendectomy and/or hernia repair; History of alcoholism or drug addiction within 1 year prior to drug administration; Tobacco or nicotine use within 6 months prior to study start; Chronic use of gastric acid inhibitors within 6 months of study start or use of gastric acid inhibitors and/or antacids within 1 month prior to drug administration; Evidence of malabsorption syndrome or other condition interfering with gastrointestinal absorption; Inability or unwillingness to swallow capsules; Participation in a drug study in which a drug was administered within 30 days prior to study start; Participation in more than one radiolabeled drug study within 12 months preceding drug administration. The previous radiolabeled study drug must have been received more than 6 months prior to this study, and the total exposure from this study and the previous study is less than 5000 mrem whole body annual exposure; Exposure to significant radiation within 12 months prior to study start.

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

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bioavailability<br> | Drug: GDC-0032<br>* Single oral dose<br>Drug: GDC-0032<br>* Single IV dose<br>|
| Experimental: Elimination & PK<br> | Drug: GDC-0032<br>* Single oral dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioavailability: Absolute bioavailability of GDC-0032 (Area under the concentration-time curve [AUC]) |  | Days 1 to 11 | 
| Elimination & PK: Amount of drug excreted in urine/feces over the sampling interval |  | Days 1 to 22 | 
| Elimination & PK: Maximum concentration (Cmax) of GDC-0032 |  | Days 1 to 22 | 
| Elimination & PK: Area under the concentration-time curve (AUC) |  | Days 1 to 22 | 
| Elimination & PK: Total radioactivity concentrations in whole blood, plasma, urine, and feces. |  | Days 1 to 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elimination & PK: Metabolite identification in plasma, urine, & feces |  | Days 1 to 22 | 
| Safety: Incidence of adverse events |  | 38 to 49 days |