A Study to Evaluate the Effect of a Proton-Pump Inhibitor (Rabeprazole) on the Relative Bioavailability of GDC 0973 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01277718
First received: January 7, 2011
Last updated: February 23, 2011
Last verified: February 2011
  Purpose

This is a Phase 1, single-center, open-label, randomized, 3-period, 2-sequence crossover study of GDC-0973 in healthy subjects to evaluate the effect of the proton pump inhibitor (PPI) rabeprazole on the relative bioavailability of GDC-0973 in healthy subjects when administered in the fed or fasted states.


Condition Intervention Phase
Healthy Volunteer
Drug: GDC-0973/XL518
Drug: rabeprazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, 3-Period, Randomized, Crossover Study to Evaluate the Effect of a Proton-Pump Inhibitor (Rabeprazole) on the Relative Bioavailability of GDC 0973 in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Area under plasma concentration-time curve [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Maximum observed concentration [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence, nature, and severity of adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: January 2011
Arms Assigned Interventions
Experimental: A Drug: GDC-0973/XL518
Oral dose in a fasted state
Experimental: B Drug: GDC-0973/XL518
Oral dose in a fasted state
Drug: rabeprazole
Repeating oral dose
Drug: rabeprazole
Oral dose in fasted state
Experimental: C Drug: GDC-0973/XL518
Oral dose in fed state
Drug: rabeprazole
Repeating oral dose
Drug: rabeprazole
Oral dose in fasted state

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Within BMI range 18.5 to 29.9 kg/m2, inclusive
  • In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
  • Clinical laboratory evaluations within the reference range for the test laboratory
  • Negative test for selected drugs of abuse at Screening (does not include alcohol) and at each Check-in
  • Negative hepatitis panel (including hepatitis B virus surface antigen [HBsAg] and hepatitis C virus antibody [anti-HCV]) and negative HIV antibody screens
  • Healthy males and females of nonchildbearing potential who agree to use effective contraception

Exclusion Criteria

  • Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
  • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
  • History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs, except that appendectomy, hernia repair, and/or cholecystectomy will be allowed
  • History or presence of an abnormal ECG
  • History of alcoholism or drug addiction within 1 year prior to Period 1 Check-in
  • Use of any tobacco- or nicotine-containing products within 6 months prior to Period 1 Check-in
  • Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to Period 1 Check-in
  • Use of any prescription medications/products within 14 days prior to Period 1 Check-in
  • Use of any over-the-counter, non-prescription preparations within 7 days prior to Period 1 Check-in
  • Use of alcohol-, grapefruit-, or caffeine-containing foods or beverages within 72 hours prior to Period 1 Check-in
  • Poor peripheral venous access
  • Any acute or chronic condition that would limit the subject's ability to complete and/or participate in this clinical study
  • Female subject is pregnant, lactating, or breastfeeding
  • Use of PPIs or histamine H2 receptor antagonists within 1 month prior to Period 1 Check-in
  • Known hypersensitivity to rabeprazole or any of its components or to derived products of benzimidazoles
  • Predisposing factors to retinal vein occlusion (RVO)
  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: NCT01277718

Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Isabelle Rooney, M.D., PhD Genentech, Inc.
  More Information

No publications provided

Responsible Party: Disclosures Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01277718     History of Changes
Other Study ID Numbers: MEK4954g
Study First Received: January 7, 2011
Last Updated: February 23, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 29, 2014