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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:8/3/2016
Start Date:November 2013
End Date:December 2013

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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

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.


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.
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Madison, WI
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