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

Completed · Phase 1

Conditions studied: Healthy Volunteer

In brief

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.

Key facts

Study ID

NCT01814709

Run by

Genentech, Inc.

People needed

32

Starts

2013-04-01

Expected to finish

2013-08-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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