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
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: 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 July 26, 2014