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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.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01814709
First received: March 18, 2013
Last updated: November 1, 2016
Last verified: November 2016
  Purpose
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

  Eligibility

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

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
  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: NCT01814709

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

Responsible Party: Genentech, Inc.
ClinicalTrials.gov 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:
Itraconazole
Hydroxyitraconazole
Rifampin
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

ClinicalTrials.gov processed this record on June 23, 2017