MedDataX Logo

A Bioavailability and Pharmacokinetic Study of GDC-0032 in Healthy Volunteers

NCT ID: NCT01967966

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

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2013-12-31

Brief Summary

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

This 2-arm, open-label, non-randomized study will investigate the absolute bioavailability, pharmacokinetics, mass balance, and routes of elimination of GDC-0032 as well as its safety in healthy volunteers. Patients will receive either a single oral dose of GDC-0032 followed by a 14C-labeled IV dose of GDC-0032 or a single oral dose of 14C-labelled GDC-0032.

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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

Bioavailability

Group Type EXPERIMENTAL

GDC-0032

Intervention Type DRUG

Single oral dose

GDC-0032

Intervention Type DRUG

Single IV dose

Elimination & PK

Group Type EXPERIMENTAL

GDC-0032

Intervention Type DRUG

Single oral dose

Interventions

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

GDC-0032

Single oral dose

Intervention Type DRUG

GDC-0032

Single IV dose

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Body Mass Index (BMI) 18 to 32 kg/m2, inclusive;
* Healthy, as judged by physician from medical history, 12-lead ECG, vital signs, and clinical laboratory evaluations;
* Agree to use effective contraceptive methods as defined by protocol;
* Negative hepatitis panel and HIV screen;
* Sufficient bowel movements (minimum of 1 per day).

Exclusion Criteria

* History or clinical manifestation of: any major medical disorders; any food/drug/substance allergies;
* History of stomach or intestinal surgery or resection except for appendectomy and/or hernia repair;
* History of alcoholism or drug addiction within 1 year prior to drug administration;
* Tobacco or nicotine use within 6 months prior to study start;
* Chronic use of gastric acid inhibitors within 6 months of study start or use of gastric acid inhibitors and/or antacids within 1 month prior to drug administration;
* Evidence of malabsorption syndrome or other condition interfering with gastrointestinal absorption;
* Inability or unwillingness to swallow capsules;
* Participation in a drug study in which a drug was administered within 30 days prior to study start;
* Participation in more than one radiolabeled drug study within 12 months preceding drug administration. The previous radiolabeled study drug must have been received more than 6 months prior to this study, and the total exposure from this study and the previous study is less than 5000 mrem whole body annual exposure;
* Exposure to significant radiation within 12 months prior to study start.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

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.

Madison, Wisconsin, 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.

GP28755

Identifier Type: -

Identifier Source: org_study_id