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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT00999128

Run by

Genentech, Inc.

People needed

50

Starts

2009-10-26

Expected to finish

2010-02-26

Last updated by the study team

2017-02-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Genentech Trial Information Support — South San Francisco, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.