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Completed

NCT Number: NCT00999128

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GDC-0941

Drug

Oral repeating dose

rabeprazole

Drug

Oral repeating dose

Primary outcomes

  1. Incidence, nature, and severity of adverse events

    Time frame: Through study completion or early study discontinuation

  2. PK parameters of GDC-0941 (total exposure, maximum and minimum plasma concentration)

    Time frame: Following administration of study drug

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

An Open-Label, Two-Part 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 21, 2009
Registry last updated
Feb 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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