Status:
COMPLETED
A Drug Interaction Study of GDC-0032 Co-administered With Rifampin or Itraconazole in Healthy Volunteers
Lead Sponsor:
Genentech, Inc.
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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, volun...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01814709
Start Date
April 1 2013
End Date
August 1 2013
Last Update
November 2 2016
Active Locations (1)
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1
Dallas, Texas, United States, 75247