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
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:

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01249118

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

No publications provided

Responsible Party: Genentech
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 April 23, 2014