Healthy Volunteers
Conditions
Keywords
PI3K inhibitor, PI3 kinase, PI3 kinase inhibitor
Brief summary
This is a Phase I, randomized, two-part, single-center pharmacokinetics (PK) study to assess the relative bioavailability of capsule and tablet formulations of GDC-0941 in the fasted state (Part 1) and to determine the effect of food and proton pump inhibition on the PK of the tablet formulation of GDC-0941 (Part 2). Approximately 18 subjects will be enrolled in Part 1 and up to 32 subjects will be enrolled in Part 2. Subjects who participate in Part 1 are not eligible to participate in Part 2.
Interventions
DRUGGDC-0941
Oral repeating dose
DRUGrabeprazole
Oral repeating dose
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female, between 18 and 65 years of age, inclusive (Part 1 only) * Male or female, between 18 and 45 years of age, inclusive (Part 2 only) * In good health, as determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), and vital signs assessment * Body Mass Index (BMI) between 18-30 kg/m\^2 inclusive, with a body weight \>50 kg * Clinical laboratory evaluations within the reference range for the test laboratory * Negative test for selected drugs of abuse at screening (does not include alcohol) and at check-in (does include alcohol) * Negative HIV, hepatitis B surface antigen (HBsAg), and hepatitis C virus antibody screens * Agreement to use an effective form of contraception for the duration of the study
Exclusion criteria
* History or clinical manifestations of significant metabolic (including type 1 and 2 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, endocrine, gastrointestinal, urological, neurological, psychiatric disorders, or cancer * History of inflammatory arthritis * History of symptomatic hypotension * History of severe physical injury, direct impact trauma, or neurological trauma within a specified timeframe prior to Day 1 * History of seizure disorders * History of bipolar or major depressive disorder * History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (exceptions: appendectomy, hernia repair, and/or cholecystectomy) * History or presence of an abnormal ECG * Subjects with a history of ventricular dysrhythmias or with risk factors for ventricular dysrhythmias * History of alcoholism, drug abuse, or drug addiction * Use of any nicotine-containing or nicotine-replacement products within a specified timeframe prior to Day 1 * Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within a specified timeframe prior to Day 1 * Use of any prescription medications/products within a specified timeframe prior to Day 1 (exceptions: hormone replacement therapy \[HRT\], oral, implantable, or transdermal contraception) * Receipt of any vaccination or immunization within a specified timeframe prior to Day 1 * Use of proton pump inhibitors or H2-receptor antagonists within a specified timeframe prior to Day 1 * Known hypersensitivity to rabeprazole or any of its components, or to derived products of benzimidazoles * Use of any over-the-counter (OTC), non-prescription preparations within a specified timeframe prior to Day 1 * Use of alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages within a specified timeframe prior to Day 1 * Poor peripheral venous access * Donation of blood or plasma within a specified timeframe prior to Day 1 * Receipt of blood products within a specified timeframe prior to Day 1 * Vegetarians who are unable to consume a high-fat meal * Women who are pregnant or nursing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, nature, and severity of adverse events | Through study completion or early study discontinuation |
| PK parameters of GDC-0941 (total exposure, maximum and minimum plasma concentration) | Following administration of study drug |
Countries
United States
Outcome results
None listed