A Study of Relative Bioavailability and Food Effect Study of GDC-0973 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT01249131
First received: November 24, 2010
Last updated: January 10, 2011
Last verified: January 2011

November 24, 2010
January 10, 2011
November 2010
Not Provided
  • PK parameters of GDC-0973 (including total exposure, maximum and minimum serum concentration, clearance, volume of distribution) [ Time Frame: Following administration of study drug ] [ Designated as safety issue: No ]
  • Incidence, nature, and severity of adverse events and serious adverse events [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01249131 on ClinicalTrials.gov Archive Site
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A Study of Relative Bioavailability and Food Effect Study of GDC-0973 in Healthy Subjects
A Phase I, Single-Dose, Randomized, Cross-Over, Relative Bioavailability, and Food Effect Study of GDC-0973 in Healthy Subjects

This study will be an open-label, randomized, 3-way, 6-sequence crossover study in healthy subjects for determining the relative bioavailability of the tablet formulation to the capsule formulation and the effect of food on the relative bioavailability of the tablet formulation.

Not Provided
Interventional
Phase 1
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy Volunteers
  • Drug: GDC-0973/XL518
    Single oral dose tablet in a fasted state
  • Drug: GDC-0973/XL518
    Single oral dose tablet in a fed state
  • Drug: GDC-0973/XL518
    Single oral dose capsules in a fasted state
  • Experimental: Treatment A
    Intervention: Drug: GDC-0973/XL518
  • Experimental: Treatment B
    Intervention: Drug: GDC-0973/XL518
  • Experimental: Treatment C
    Intervention: Drug: GDC-0973/XL518
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
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Inclusion Criteria

  • Within body mass index (BMI) range 18.5 to 29.9 kg/m2
  • In good health, determined by no clinically significant findings from medical history
  • Clinical laboratory evaluations within the reference range for the test laboratory
  • Negative test for selected drugs of abuse at Screening and at each Check-in
  • Negative hepatitis panel and anti-hepatitis C virus and negative HIV antibody screens
  • Healthy males and females of non-child-bearing potential or 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 cholecystectomy will be allowed
  • History or presence of an abnormal electrocardiogram (ECG)
  • History of alcoholism or drug addiction prior to study start
  • Use of any tobacco-containing or nicotine-containing products prior to study start
  • Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 28 days or 5 half-lives, whichever is longer, prior to study start
  • Use of any prescription medications/products, including proton pump inhibitors, within 14 days prior to study start
  • 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
  • Predisposing factors to retinal vein occlusion (RVO)
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT01249131
MEK4953g
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Disclosures Group, Genentech, Inc.
Genentech
Not Provided
Study Director: Isabelle Rooney, M.D., PhD Genentech
Genentech
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP