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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: GDC-0032; Drug: Rifampin; Drug: Itraconazole

• Registration Number: NCT01814709
• Lead Sponsor: Genentech, Inc.

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, 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-18
• Study First Submitted QC: 2013-03-18
• Study First Posted: 2013-03-20
• Study Start: 2013-04
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rifampin Arm	Rifampin	-
Itraconazole Arm	GDC-0032	-
Rifampin Arm	GDC-0032	-
Itraconazole Arm	Itraconazole	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics: Plasma concentrations of GDC-0032	2 months
Safety: Incidence of adverse events	2 months