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An Absolute Bioavailability Study in Healthy Subjects Comparing Oral to Intravenous Administration of GDC-0973

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01249118
First received: November 24, 2010
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

The primary objective of Part 1 of this study is to evaluate the safety and tolerability of the intravenous (IV) dose of GDC-0973. The primary objectives of Part 2 of this study are to evaluate the absolute bioavailability of GDC-0973 and to evaluate the pharmacokinetic (PK) of GDC-0973 following IV and oral administration. The secondary objective of Part 2 of this study is to evaluate the safety of GDC-0973 administered orally and intravenously.


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 1, Single Dose, Randomized, Cross-over Absolute Bioavailability Study in Healthy Subjects Comparing Oral to Intravenous Administration of GDC-0973

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • PK parameters of GDC-0973 (including total exposure, maximum and minimum serum concentration, clearance, volume of distribution at steady state, absolute bioavailability) [ 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: 13
Study Start Date: November 2010
Arms Assigned Interventions
Experimental: A Drug: GDC-0973/XL518
Each subject will receive a single IV dose and oral dose separated by 10 days

  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: NCT01249118

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

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01249118     History of Changes
Other Study ID Numbers: MEK4952g
Study First Received: November 24, 2010
Last Updated: August 16, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 23, 2014