Clinical trial NCT01814709: A Drug Interaction Study of GDC-0032 Co-administered With Rifampin or Itraconazole in Healthy Volunteers
Official title: A Phase 1, Open-Label Study to Evaluate the Effect of Rifampin or Itraconazole on the Pharmacokinetics of GDC-0032 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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

Primary outcomes:
measure: Pharmacokinetics: Plasma concentrations of GDC-0032
timeFrame: 2 months
measure: Safety: Incidence of adverse events
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
state: Texas
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: