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

Genentech

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: GDC-0032

Study type

Interventional

Funder types

Industry

Identifiers

NCT01967966

GP28755

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.