A 3-Part Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0980, the Effect of Food, and the Effect of Rabeprazole on the Pharmacokinetics of the Tablet

An Open-Label, 3-Part Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0980, the Effect of Food, and the Effect of Rabeprazole on the Pharmacokinetics of the Tablet

This will be a single-center, open-label, 3 part study. The study is designed to determine the relative bioavailability of GDC-0980 capsule and tablet formulations under fasting conditions, the effects of a high-fat (fed) meal on the pharmacokinetics of the GDC-0980 tablet, and the effects of rabeprazole on the pharmacokinetics of the GDC-0980 tablet in the presence or absence of a high-fat meal.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: GDC-0980; Drug: GDC-0980; Drug: GDC-0980; Drug: GDC-0980; Drug: GDC-0980; Drug: GDC-0980; Drug: rabeprazole

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria

• Nonsmoking with a body mass index of 18 to 32 kg/m2
• Medically healthy as determined by the absence of clinically significant findings in the physical examination, medical history, vital sign measurements, clinical laboratory tests, or 12-lead electrocardiograms (ECGs)
• Nonchildbearing potential, defined as either postmenopausal and without recent history of menorrhea or surgically sterile

Exclusion Criteria

• History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, endocrine, gastrointestinal, urological, neurological, or psychiatric disorders, or cancer
• History of inflammatory arthritis
• History of symptomatic hypotension
• History of severe physical injury, direct impact trauma, or neurological trauma within 6 months prior to study start
• History of seizure disorders
• History of bipolar or major depressive disorder
• History of stomach or intestinal surgery or resection that could potentially alter absorption and/or excretion of orally administered drugs with the exception of appendectomy, hernia repair, and cholecystectomy, which are allowed
• History or presence of an abnormal ECG
• History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias
• Abnormality on the chest x-ray at Screening
• History of alcoholism, drug abuse, or drug addiction
• Used any nicotine-containing or nicotine-replacement products within 6 months prior to study start
• Participated in any other investigational drug study in which receipt of an investigational study drug occurred within 1 month or 5 half-lives prior to study start
• Used any prescription medications/products including monoamine oxidase inhibitors, thioridazine, pimozide, or antidepressants within 1 month (2 weeks for antibiotics) prior to study start, with the exception of hormone-replacement therapy or 2 weeks' use of narcotics for pain
• Received any vaccination or immunization within 1 month prior to study start
• Used PPIs or histamine H2-receptor antagonists within 1 month prior to study start
• Hypersensitivity to rabeprazole, or any of its components, or to derived products of benzimidazoles (for Part 3 only)
• Poor peripheral venous access
• Received blood products within 2 months prior to study start
• Positive urine drug or alcohol screen
• Positive screen for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus types 1 and 2
• Unable to consume a high-fat meal (for Parts 2 and 3 only)
• Acute or chronic condition that would limit the subject's ability to complete or participate in this clinical study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1	Drug: GDC-0980; Oral tablet dose; Drug: GDC-0980; Oral capsule dose; Drug: GDC-0980; Oral tablet dose in fed state; Drug: GDC-0980; Oral repeating dose in fasting state; Drug: GDC-0980; Oral repeating dose in fed state; Drug: GDC-0980; Oral tablet in a fasting state
Experimental: Part 2	Drug: GDC-0980; Oral tablet dose; Drug: GDC-0980; Oral capsule dose; Drug: GDC-0980; Oral tablet dose in fed state; Drug: GDC-0980; Oral repeating dose in fasting state; Drug: GDC-0980; Oral repeating dose in fed state; Drug: GDC-0980; Oral tablet in a fasting state
Experimental: Part 3: Group A	Drug: GDC-0980; Oral tablet dose; Drug: GDC-0980; Oral capsule dose; Drug: GDC-0980; Oral tablet dose in fed state; Drug: GDC-0980; Oral repeating dose in fasting state; Drug: GDC-0980; Oral repeating dose in fed state; Drug: GDC-0980; Oral tablet in a fasting state; Drug: rabeprazole; Oral repeating dose
Experimental: Part 3: Group B	Drug: GDC-0980; Oral tablet dose; Drug: GDC-0980; Oral capsule dose; Drug: GDC-0980; Oral tablet dose in fed state; Drug: GDC-0980; Oral repeating dose in fasting state; Drug: GDC-0980; Oral repeating dose in fed state; Drug: GDC-0980; Oral tablet in a fasting state; Drug: rabeprazole; Oral repeating dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum plasma concentration	Up to day 10
Time to maximum observed plasma concentration	Up to day 10
Plasma half-life	Up to day 10
Oral clearance	Up to day 10
Volume of distribution	Up to day 10
Minimum plasma concentration	Up to day 10

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events	Up to day 68
Nature of adverse events	Up to day 68
Severity of adverse events	Up to day 68

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2010
• Primary Completion (Actual): February 3, 2011
• Study Completion (Actual): February 3, 2011

Study Registration Dates

• First Submitted: January 7, 2011
• First Submitted That Met QC Criteria: January 28, 2011
• First Posted (Estimate): February 1, 2011

Study Record Updates

• Last Update Posted (Estimate): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 9, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole
• Other Study ID Numbers: PIM4930g

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No