MedDataX Logo

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

NCT ID: NCT01814709

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Itraconazole Arm

Group Type EXPERIMENTAL

GDC-0032

Intervention Type DRUG

Oral doses of GDC-0032

Itraconazole

Intervention Type DRUG

Oral doses of Itraconazole

Rifampin Arm

Group Type EXPERIMENTAL

GDC-0032

Intervention Type DRUG

Oral doses of GDC-0032

Rifampin

Intervention Type DRUG

Oral doses of Rifampin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GDC-0032

Oral doses of GDC-0032

Intervention Type DRUG

Itraconazole

Oral doses of Itraconazole

Intervention Type DRUG

Rifampin

Oral doses of Rifampin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dallas, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GP28617

Identifier Type: -

Identifier Source: org_study_id