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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:8/3/2016
Start Date:April 2013
End Date:August 2013

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

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.


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
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