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

A Phase 1, Open-Label Study to Evaluate the Effect of Rifampin or Itraconazole on the Pharmacokinetics of GDC-0032 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01814709

Enrollment

Registered

2013-03-20

Start date

2013-04-30

Completion date

2013-08-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

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.

Interventions

DRUGGDC-0032

Oral doses of GDC-0032

DRUGItraconazole

Oral doses of Itraconazole

DRUGRifampin

Oral doses of Rifampin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: Plasma concentrations of GDC-0032	2 months
Safety: Incidence of adverse events	2 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026