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Single Dose Study To Study The Absorption, Metabolism And Excretion Of PF-04991532

NCT ID: NCT01469481

Last Updated: 2012-01-31

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

2011-11-30

Study Completion Date

2011-11-30

Brief Summary

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The purpose of this study is to evaluate the excretion balance, metabolic profile and the routes of excretion of \[14C\]PF-04991532 in healthy adult male subjects.

Detailed Description

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Conditions

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Healthy

Keywords

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diabetes mellitus ADME

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

PF-04991532

Intervention Type DRUG

a single oral dose of \[14C\]PF-04991532 (450 mg/100 uCi suspension)

Interventions

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PF-04991532

a single oral dose of \[14C\]PF-04991532 (450 mg/100 uCi suspension)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg(110 lbs).
* An informed consent document signed and dated by the subject.

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or clinical findings at Screening.
* History of irregular bowel movements (eg, irritable bowel syndrome or frequent episodes of diarrhea or constipation).
* Any condition possibly affecting drug absorption (eg, appendectomy, gastrectomy).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Tacoma, Washington, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2611007&StudyName=Single%20Dose%20Study%20To%20Study%20The%20Absorption%2C%20Metabolism%20And%20Excretion%20Of%20PF-04991532

To obtain contact information for a study center near you, click here.

Other Identifiers

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B2611007

Identifier Type: -

Identifier Source: org_study_id