Healthy Volunteer
Conditions
Brief summary
This will be a single-center, open-label, 3 part study. The study is designed to determine the relative bioavailability of GDC-0980 capsule and tablet formulations under fasting conditions, the effects of a high-fat (fed) meal on the pharmacokinetics of the GDC-0980 tablet, and the effects of rabeprazole on the pharmacokinetics of the GDC-0980 tablet in the presence or absence of a high-fat meal.
Interventions
DRUGGDC-0980
Oral tablet dose
DRUGrabeprazole
Oral repeating dose
Sponsors
Genentech, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimum plasma concentration | Up to day 10 |
| Plasma half-life | Up to day 10 |
| Oral clearance | Up to day 10 |
| Volume of distribution | Up to day 10 |
| Maximum plasma concentration | Up to day 10 |
| Time to maximum observed plasma concentration | Up to day 10 |
Secondary
| Measure | Time frame |
|---|---|
| Nature of adverse events | Up to day 68 |
| Severity of adverse events | Up to day 68 |
| Incidence of adverse events | Up to day 68 |
Countries
United States
Outcome results
None listed