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 study has been completed.
Sponsor:
Information provided by:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00999128
First received: October 19, 2009
Last updated: February 25, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: GDC-0941
Drug: rabeprazole
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Incidence, nature, and severity of adverse events [ Time Frame: Through study completion or early study discontinuation ]
  • PK parameters of GDC-0941 (total exposure, maximum and minimum plasma concentration) [ Time Frame: Following administration of study drug ]

Enrollment: 50
Study Start Date: October 2009
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1 Drug: GDC-0941
Oral repeating dose
Experimental: Part 2 Drug: GDC-0941
Oral repeating dose
Drug: rabeprazole
Oral repeating dose

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999128

Locations
United States, California
Genentech Trial Information Support
South San Francisco, California, United States, 94080
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Scott Holden, M.D. Genentech, Inc.
  More Information

No publications provided

Responsible Party: Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00999128     History of Changes
Other Study ID Numbers: GDC4740g
Study First Received: October 19, 2009
Last Updated: February 25, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Genentech, Inc.:
PI3K inhibitor
PI3 kinase
PI3 kinase inhibitor

ClinicalTrials.gov processed this record on October 20, 2014