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

NCT ID: NCT01287091

Last Updated: 2022-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-14
• Study Completion Date: 2011-02-03

Brief Summary

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.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1

Group Type: EXPERIMENTAL

GDC-0980

Intervention Type: DRUG

Oral tablet dose

GDC-0980

Intervention Type: DRUG

Oral capsule dose

Part 2

Group Type: EXPERIMENTAL

GDC-0980

Intervention Type: DRUG

Oral tablet dose in fed state

GDC-0980

Intervention Type: DRUG

Oral tablet in a fasting state

Part 3: Group A

Group Type: EXPERIMENTAL

GDC-0980

Intervention Type: DRUG

Oral repeating dose in fasting state

rabeprazole

Intervention Type: DRUG

Oral repeating dose

Part 3: Group B

Group Type: EXPERIMENTAL

GDC-0980

Intervention Type: DRUG

Oral repeating dose in fed state

rabeprazole

Intervention Type: DRUG

Oral repeating dose

Interventions

GDC-0980

Oral tablet dose

Intervention Type: DRUG

GDC-0980

Oral capsule dose

Intervention Type: DRUG

GDC-0980

Oral tablet dose in fed state

Intervention Type: DRUG

GDC-0980

Oral repeating dose in fasting state

Intervention Type: DRUG

GDC-0980

Oral repeating dose in fed state

Intervention Type: DRUG

GDC-0980

Oral tablet in a fasting state

Intervention Type: DRUG

rabeprazole

Oral repeating dose

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Holden, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

Investigational Site

Austin, Texas, United States

Countries

United States

Other Identifiers

PIM4930g

Identifier Type: -

Identifier Source: org_study_id