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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00999128
• Other study ID #: GDC4740g
• Status: Completed
• Phase: Phase 1
• First received: October 19, 2009
• Last updated: February 7, 2017
• Start date: October 26, 2009
• Est. completion date: February 26, 2010

Study information

• Verified date: February 2010
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 26, 2010
• Est. primary completion date: February 26, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• GDC-0941
Oral repeating dose
• rabeprazole
Oral repeating dose

Locations

Country	Name	City	State
United States	Genentech Trial Information Support	South San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence, nature, and severity of adverse events		Through study completion or early study discontinuation
Primary	PK parameters of GDC-0941 (total exposure, maximum and minimum plasma concentration)		Following administration of study drug