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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01287091
• Other study ID #: PIM4930g
• Status: Completed
• Phase: Phase 1
• Start date: October 14, 2010
• Est. completion date: February 3, 2011

Study information

• Verified date: December 2022
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 3, 2011
• Est. primary completion date: February 3, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• GDC-0980
Oral tablet dose
• GDC-0980
Oral capsule dose
• GDC-0980
Oral tablet dose in fed state
• GDC-0980
Oral repeating dose in fasting state
• GDC-0980
Oral repeating dose in fed state
• GDC-0980
Oral tablet in a fasting state
• rabeprazole
Oral repeating dose

Locations

Country	Name	City	State
United States	Investigational Site	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration		Up to day 10
Primary	Time to maximum observed plasma concentration		Up to day 10
Primary	Plasma half-life		Up to day 10
Primary	Oral clearance		Up to day 10
Primary	Volume of distribution		Up to day 10
Primary	Minimum plasma concentration		Up to day 10
Secondary	Incidence of adverse events		Up to day 68
Secondary	Nature of adverse events		Up to day 68
Secondary	Severity of adverse events		Up to day 68