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A Study of the Hedgehog Pathway Inhibitor GDC-0449 in Healthy Female Subjects of Non-Childbearing Potential

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00991718
First Posted: October 8, 2009
Last Update Posted: June 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genentech, Inc.
October 6, 2009
October 8, 2009
June 26, 2017
September 2009
August 2010   (Final data collection date for primary outcome measure)
PK (Max observed and time to max plasma concentrations, area under the plasma concentration-time curve, absolute bioavailability, total plasma clearance, vol of dist, plasma terminal phase half-life, cumulative % excretion in urine and feces [Part B]) [ Time Frame: Until study discontinuation ]
Same as current
Complete list of historical versions of study NCT00991718 on ClinicalTrials.gov Archive Site
Safety outcome measures (incidence, nature, and severity of adverse events; change in clinical laboratory results; change in vital signs; change in electrocardiogram [ECG]; and change in physical examination findings) [ Time Frame: Until study discontinuation ]
Same as current
Not Provided
Not Provided
 
A Study of the Hedgehog Pathway Inhibitor GDC-0449 in Healthy Female Subjects of Non-Childbearing Potential
A Phase I, Open-Label Absorption, Distribution, Metabolism, and Excretion (ADME) Study of the Hedgehog Pathway Inhibitor GDC-0449 in Healthy Female Subjects of Non-Childbearing Potential
This is an open-label, Phase I, single-center, single-dose administration study to determine the absolute bioavailability, clearance, and volume of distribution of GDC-0449 (Part A) and to determine the routes of excretion and extent of metabolism of GDC-0449 (Part B). Parts A and B will be conducted sequentially, with ≥ 7 days between dosing the sixth subject in Part A and dosing the first subject in Part B. In each part, 6 healthy female subjects of non-childbearing potential, between 18 and 65 years of age (inclusive), will be dosed.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy
  • Drug: GDC-0449 oral capsules (non-labeled)
    150 mg oral capsule
  • Drug: GDC-0449 IV injection (labeled)
    10 mcg (in 2 mL) IV dose of 14C-GDC-0449
  • Drug: CDC-0449 oral suspension (labeled)
    30-mL oral suspension containing 6.5 mcg 14CGDC-0449 and 150 mg GDC-0449
  • Experimental: A
    On Day 1, subjects received a single oral dose of non-labeled GDC-0449 and a single IV tracer dose of 14C-GDC-0449.
    Interventions:
    • Drug: GDC-0449 oral capsules (non-labeled)
    • Drug: GDC-0449 IV injection (labeled)
  • Experimental: B
    On Day 1, subjects received a single oral dose of 14C-GDC-0449.
    Intervention: Drug: CDC-0449 oral suspension (labeled)
  • Experimental: C
    On Days 1−7, subjects received a single oral dose of non-labeled GDC-0449. On Day 7, subjects also received a single IV tracer dose of 14C-GDC-0449.
    Interventions:
    • Drug: GDC-0449 oral capsules (non-labeled)
    • Drug: GDC-0449 IV injection (labeled)
  • Experimental: D
    On Days 1−6, subjects received a single oral dose of non-labeled GDC-0449. On Day 7, subjects received a single oral dose of 14C-GDC-0449.
    Interventions:
    • Drug: GDC-0449 oral capsules (non-labeled)
    • Drug: CDC-0449 oral suspension (labeled)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
August 2010
August 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria

  • Female
  • Non-childbearing potential
  • Body mass index (BMI) between 18 and 32 kg/m^2, inclusive
  • In good health, determined by no clinically significant findings on physical examination, medical history, 12-lead ECG, and vital signs
  • Negative test for drugs of abuse at screening (does not include alcohol) and at admission to the clinical research facility (does include alcohol)

Exclusion Criteria

  • History or clinical manifestations of clinically significant metabolic, hepatic, renal, hematologic, pulmonary, cardiovascular, endocrine, gastrointestinal (including gastric or duodenal ulcers), urologic, neurologic, inflammatory, or psychiatric disorders, or cancer
  • History of symptomatic hypotension, idiopathic orthostatic hypotension, or other autonomous-failure syndromes
  • History of severe physical injury, direct impact trauma, or neurological trauma within 6 months prior to Day -1
  • History of stomach or intestinal surgery, stomach disease, or resection that would potentially alter absorption and/or excretion of orally administered drugs (appendectomy, hernia repair, and/or cholecystectomy are allowed)
  • History of alcoholism, drug abuse, or drug addiction (including soft drugs like cannabis products)
  • Use of any prescription medications/products, including known enzyme-inducing/inhibiting agents, over-the-counter medication, or other non-prescription preparations (including supplements, vitamins, minerals, phytotherapeutic/herbal/ plant-derived preparations, the tryptophans, and St. John's wort or other hypericum perforatum-containing substance) within 2 weeks prior to Day -1, with the exception of hormone-replacement therapy
  • Participation in any other investigational drug study in which receipt of an investigational study drug occurred within 60 days prior to Day -1 or within 5 times the elimination half-life of the respective drug; participation in a trial involving administration of ^1^4C-radiolabeled compound(s) within 6 months prior to Day -1; participation in more than two other drug trials within 1 year prior to Day -1
  • Receipt of any vaccination or immunization within 1 month prior to Day -1
  • Use of any nicotine-containing or nicotine-replacement products within 6 months prior to Day -1
  • Consumption of alcohol or methylxanthine-containing beverages or food
  • Receipt of blood products within 2 months prior to Day -1
  • Donation of > 100 mL of blood within 60 days prior to Day -1; donation of > 1.0 litres of blood within 10 months prior to Day -1
  • Irregular defecation pattern, i.e., less than once per 2 days within 6 months prior to Day -1; acute constipation problems within 3 weeks prior to Day -1 (Part B subjects only)
  • Poor peripheral venous access
Sexes Eligible for Study: Female
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
Netherlands
 
NCT00991718
SHH4683g
Not Provided
Not Provided
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Jennifer Low, M.D. Genentech, Inc.
Genentech, Inc.
June 2017

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