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NCT Number: NCT01287091

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GDC-0980

Drug

Oral tablet dose

rabeprazole

Drug

Oral repeating dose

Primary outcomes

  1. Maximum plasma concentration

    Time frame: Up to day 10

  2. Time to maximum observed plasma concentration

    Time frame: Up to day 10

  3. Plasma half-life

    Time frame: Up to day 10

  4. Oral clearance

    Time frame: Up to day 10

  5. Volume of distribution

    Time frame: Up to day 10

  6. Minimum plasma concentration

    Time frame: Up to day 10

Secondary outcomes

  1. Incidence of adverse events

    Time frame: Up to day 68

  2. Nature of adverse events

    Time frame: Up to day 68

  3. Severity of adverse events

    Time frame: Up to day 68

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 1, 2011
Registry last updated
Dec 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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