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

This study has been completed.
Sponsor:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00991718
First received: October 6, 2009
Last updated: September 22, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: GDC-0449
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: October 2009
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: GDC-0449
oral dosage administration, intravenous dosage administration
Experimental: B Drug: GDC-0449
oral dosage administration

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00991718

Sponsors and Collaborators
Genentech
Investigators
Study Director: Jennifer Low, M.D. Genentech
  More Information

No publications provided

Responsible Party: Disclosures Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00991718     History of Changes
Other Study ID Numbers: SHH4683g
Study First Received: October 6, 2009
Last Updated: September 22, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
GDC0449

ClinicalTrials.gov processed this record on April 16, 2014