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

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Hydroxyitraconazole; Itraconazole; Rifampin

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