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A Pharmacokinetics Study of Radioactive-Labeled GDC-0973 in Healthy Male Volunteers

NCT ID: NCT01711762

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-09-30

Brief Summary

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This open-label, non-randomized study will assess the absorption, metabolism, and excretion of radioactive-labeled \[14C\]-GDC-0973 in healthy male volunteers. Volunteers will receive a single dose of \[14C\]-GDC-0973.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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GDC-0973 Single Arm

Group Type EXPERIMENTAL

GDC-0973

Intervention Type DRUG

Single oral dose of \[14C\]-GDC-0973

Interventions

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GDC-0973

Single oral dose of \[14C\]-GDC-0973

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body mass index (BMI) between 18.5 and 29.9 kg/m2, inclusive
* No clinically significant findings from medical history, 12-lead ECG, and vital signs and laboratory evaluations
* Negative test for selected drugs of abuse
* No infection with hepatitis B, hepatitis C, human immunodeficiency virus (HIV)
* Sterile or agree to use an adequate contraception method
* Historically able to produce a minimum of 1 bowel movement per day

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 unless approved by the Investigator
* History of stomach or intestinal surgery or resection (including a cholecystectomy) that would potentially alter absorption and/or excretion of orally administered drugs except that appendectomy and/or hernia repair will be allowed
* History of Gilbert's Syndrome
* History of diabetes mellitus and/or elevated fasting glucose at baseline
* History or presence of an abnormal ECG
* History of alcoholism or drug addiction within 1 year prior Check-in
* Participation in more than one other radiolabeled investigational study drug trial within 12 months prior to Check-in
* Exposure to significant radiation within 12 months prior to Check-in study drug occurred within 5 half-lives or 30 days, whichever is longer, prior to Check-in
* Use of any tobacco-containing or nicotine-containing products within 6 months prior to Check-in
* 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, prior to Check-in
* Use of any prescription medications/products within 14 days prior to Check-in
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

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Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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GP28369

Identifier Type: -

Identifier Source: org_study_id