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Trial record 2 of 14 for:    gdc0032

A Drug Interaction Study of GDC-0032 Co-administered With Rifampin or Itraconazole in Healthy Volunteers

This study has been completed.
Information provided by (Responsible Party):
Genentech, Inc. Identifier:
First received: March 18, 2013
Last updated: November 1, 2016
Last verified: November 2016
This open-label, two-arm, drug interaction study will investigate the effect of co-administration of rifampin or itraconazole on the pharmacokinetics of GDC-0032 in healthy volunteers. In Arm A, volunteers will receive GDC-0032 and rifampin; in Arm B, volunteers will receive GDC-0032 and itraconazole. The anticipated time on study treatment is approximately 30 days.

Condition Intervention Phase
Healthy Volunteer Drug: GDC-0032 Drug: Itraconazole Drug: Rifampin Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Phase 1, Open-Label Study to Evaluate the Effect of Rifampin or Itraconazole on the Pharmacokinetics of GDC-0032 in Healthy Subjects

Resource links provided by NLM:

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Pharmacokinetics: Plasma concentrations of GDC-0032 [ Time Frame: 2 months ]
  • Safety: Incidence of adverse events [ Time Frame: 2 months ]

Enrollment: 32
Study Start Date: April 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Itraconazole Arm Drug: GDC-0032
Oral doses of GDC-0032
Drug: Itraconazole
Oral doses of Itraconazole
Experimental: Rifampin Arm Drug: GDC-0032
Oral doses of GDC-0032
Drug: Rifampin
Oral doses of Rifampin


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Female volunteers will be non-pregnant, non-lactating, and either postmenopausal for at least 1 year or surgically sterile
  • Male volunteers will either be sterile, or agree to use adequate methods of contraception
  • Body mass index (BMI) range 18 to 32 kg/m2, inclusive
  • No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs; and clinical laboratory evaluations
  • Negative hepatitis B virus, hepatitis C virus and negative HIV antibody screens

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 alter absorption and/or excretion of orally administered study drugs
  • History of alcoholism or drug addiction within 1 year prior to Check-in
  • History of chronic proton pump inhibitor (PPI) use within 6 months of Check-in, or use of PPIs, H2-receptor antagonists, or antacids within 1 month prior to Check-in and during the entire study
  • Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
  • History type 1 or 2 diabetes and/or elevated fasting glucose at baseline
  • Malabsorption syndrome or other condition that would interfere with enteral absorption
  • Use of any tobacco- or nicotine containing- products
  • Participation in any other investigational study drug or biologic agent trial in which receipt of an investigational study drug occurred within 5 half-lives or 30 days, whichever is longer to Check-in and during the entire study duration
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Please refer to this study by its identifier: NCT01814709

United States, Texas
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Genentech, Inc.
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc. Identifier: NCT01814709     History of Changes
Other Study ID Numbers: GP28617
Study First Received: March 18, 2013
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers processed this record on June 23, 2017