A Phase 1, Open-Label Study to Evaluate the Effect of Rifampin or Itraconazole on the Pharmacokinetics of GDC-0032 in Healthy Subjects

Genentech, Inc.0 sites32 target enrollmentApril 2013

ConditionsHealthy Volunteer

InterventionsItraconazole Rifampin GDC-0032

DrugsGDC-0032 Itraconazole Rifampin

Overview

Phase: Phase 1
Intervention: Itraconazole
Conditions: Healthy Volunteer
Sponsor: Genentech, Inc.
Enrollment: 32
Primary Endpoint: Pharmacokinetics: Plasma concentrations of GDC-0032
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 2013

End Date

August 2013

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility 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