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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00991718
• Date of registration: 06/10/2009
• Primary sponsor: Genentech
• Public title: A Study of the Hedgehog Pathway Inhibitor GDC-0449 in Healthy Female Subjects of Non-Childbearing Potential
• Scientific 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
• Date of first enrolment: October 2009
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00991718
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Netherlands

Contacts

• Name: Jennifer Low, M.D.
• Affiliation: Genentech

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: GDC-0449

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

Secondary ID(s)

SHH4683g

Source(s) of Monetary Support

Please refer to primary and secondary sponsors