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
  Purpose

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.


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

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Phase I, Single-Dose, Randomized, Cross-Over, Relative Bioavailability, and Food Effect Study of GDC-0973 in Healthy Subjects

Further study details as provided by Genentech:

Primary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: November 2010
Arms Assigned Interventions
Experimental: Treatment A Drug: GDC-0973/XL518
Single oral dose tablet in a fasted state
Experimental: Treatment B Drug: GDC-0973/XL518
Single oral dose capsules in a fasted state
Experimental: Treatment C Drug: GDC-0973/XL518
Single oral dose tablet in a fed state

  Eligibility

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

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)
  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: NCT01249131

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: NCT01249131     History of Changes
Other Study ID Numbers: MEK4953g
Study First Received: November 24, 2010
Last Updated: January 10, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 01, 2014