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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01814709
• Other study ID #: GP28617
• Status: Completed
• Phase: Phase 1
• First received: March 18, 2013
• Last updated: November 1, 2016
• Start date: April 2013
• Est. completion date: August 2013

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• GDC-0032
Oral doses of GDC-0032
• Itraconazole
Oral doses of Itraconazole
• Rifampin
Oral doses of Rifampin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Plasma concentrations of GDC-0032		2 months	No
Primary	Safety: Incidence of adverse events		2 months	No