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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
ClinicalTrials.gov Identifier:
NCT01277718
First received: January 7, 2011
Last updated: February 23, 2011
Last verified: February 2011
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Genentech:

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01277718

Sponsors and Collaborators
Genentech
Investigators
Study Director: Isabelle Rooney, M.D., PhD Genentech
  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:
Rabeprazole
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013