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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: GDC-0032; Drug: GDC-0032

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bioavailability	Drug: GDC-0032; Single oral dose; Drug: GDC-0032; Single IV dose
Experimental: Elimination & PK	Drug: GDC-0032; Single oral dose; Drug: GDC-0032; Single IV dose

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: October 18, 2013
• First Submitted That Met QC Criteria: October 18, 2013
• First Posted (Estimate): October 23, 2013

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: GP28755