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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: GDC-0032
* Drug: Itraconazole
* Drug: Rifampin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Itraconazole Arm<br> | Drug: GDC-0032<br>* Oral doses of GDC-0032<br>Drug: Itraconazole<br>* Oral doses of Itraconazole<br>|
| Experimental: Rifampin Arm<br> | Drug: GDC-0032<br>* Oral doses of GDC-0032<br>Drug: Rifampin<br>* Oral doses of Rifampin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Plasma concentrations of GDC-0032 |  | 2 months | 
| Safety: Incidence of adverse events |  | 2 months |