Status:
COMPLETED
A Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0941 and the Effect of Food and Proton Pump Inhibition on GDC-0941 Tablet Pharmacokinetics in Healthy Volunteers
Lead Sponsor:
Genentech, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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) an...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 26 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00999128
Start Date
October 26 2009
End Date
February 26 2010
Last Update
February 9 2017
Active Locations (1)
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1
Genentech Trial Information Support
South San Francisco, California, United States, 94080