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 |
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.
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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