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

Genentech

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: Itraconazole

Drug: GDC-0032

Drug: Rifampin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01814709

GP28617

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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