A 3-Part Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0980, the Effect of Food, and the Effect of Rabeprazole on the Pharmacokinetics of the Tablet
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–65
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible if
Nonsmoking with a body mass index of 18 to 32 kg/m2
Medically healthy as determined by the absence of clinically significant findings in the physical examination, medical history, vital sign measurements, clinical laboratory tests, or 12-lead electrocardiograms (ECGs)
Nonchildbearing potential, defined as either postmenopausal and without recent history of menorrhea or surgically sterile
You may not be if
History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, endocrine, gastrointestinal, urological, neurological, or psychiatric disorders, or cancer
History of inflammatory arthritis
History of symptomatic hypotension
History of severe physical injury, direct impact trauma, or neurological trauma within 6 months prior to study start
History of seizure disorders
History of bipolar or major depressive disorder
History of stomach or intestinal surgery or resection that could potentially alter absorption and/or excretion of orally administered drugs with the exception of appendectomy, hernia repair, and cholecystectomy, which are allowed
History or presence of an abnormal ECG
History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias
Abnormality on the chest x-ray at Screening
History of alcoholism, drug abuse, or drug addiction
Used any nicotine-containing or nicotine-replacement products within 6 months prior to study start
Participated in any other investigational drug study in which receipt of an investigational study drug occurred within 1 month or 5 half-lives prior to study start
Used any prescription medications/products including monoamine oxidase inhibitors, thioridazine, pimozide, or antidepressants within 1 month (2 weeks for antibiotics) prior to study start, with the exception of hormone-replacement therapy or 2 weeks' use of narcotics for pain
Received any vaccination or immunization within 1 month prior to study start
Used PPIs or histamine H2-receptor antagonists within 1 month prior to study start
Hypersensitivity to rabeprazole, or any of its components, or to derived products of benzimidazoles (for Part 3 only)
Poor peripheral venous access
Received blood products within 2 months prior to study start
Positive urine drug or alcohol screen
Positive screen for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus types 1 and 2
Unable to consume a high-fat meal (for Parts 2 and 3 only)
Acute or chronic condition that would limit the subject's ability to complete or participate in this clinical study
