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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

Information source: Genentech, Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteer

Intervention: GDC-0980 (Drug); GDC-0980 (Drug); GDC-0980 (Drug); GDC-0980 (Drug); GDC-0980 (Drug); GDC-0980 (Drug); rabeprazole (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Genentech, Inc.

Official(s) and/or principal investigator(s):
Scott Holden, M.D., Study Director, Affiliation: Genentech, Inc.

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.

Clinical Details

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

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Maximum plasma concentration

Time to maximum observed plasma concentration

Plasma half-life

Oral clearance

Volume of distribution

Minimum plasma concentration

Secondary outcome:

Incidence of adverse events

Nature of adverse events

Severity of adverse events

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Female.

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

Locations and Contacts

Investigational Site, Austin, Texas 78744, United States
Additional Information

Starting date: October 2010
Last updated: August 19, 2011

Page last updated: August 20, 2015

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