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 study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01287091
First received: January 7, 2011
Last updated: August 19, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Healthy Volunteer
Drug: GDC-0980
Drug: rabeprazole
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Maximum plasma concentration [ Time Frame: Up to day 10 ] [ Designated as safety issue: No ]
  • Time to maximum observed plasma concentration [ Time Frame: Up to day 10 ] [ Designated as safety issue: No ]
  • Plasma half-life [ Time Frame: Up to day 10 ] [ Designated as safety issue: No ]
  • Oral clearance [ Time Frame: Up to day 10 ] [ Designated as safety issue: No ]
  • Volume of distribution [ Time Frame: Up to day 10 ] [ Designated as safety issue: No ]
  • Minimum plasma concentration [ Time Frame: Up to day 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: Up to day 68 ] [ Designated as safety issue: No ]
  • Nature of adverse events [ Time Frame: Up to day 68 ] [ Designated as safety issue: No ]
  • Severity of adverse events [ Time Frame: Up to day 68 ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: October 2010
Arms Assigned Interventions
Experimental: Part 1 Drug: GDC-0980
Oral tablet dose
Drug: GDC-0980
Oral capsule dose
Experimental: Part 2 Drug: GDC-0980
Oral tablet dose in fed state
Drug: GDC-0980
Oral tablet in a fasting state
Experimental: Part 3: Group A Drug: GDC-0980
Oral repeating dose in fasting state
Drug: rabeprazole
Oral repeating dose
Experimental: Part 3: Group B Drug: GDC-0980
Oral repeating dose in fed state
Drug: rabeprazole
Oral repeating dose

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287091

Locations
United States, Texas
Investigational Site
Austin, Texas, United States, 78744
Sponsors and Collaborators
Genentech
Investigators
Study Director: Scott Holden, M.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01287091     History of Changes
Other Study ID Numbers: PIM4930g
Study First Received: January 7, 2011
Last Updated: August 19, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rabeprazole
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014