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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014