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A Study To Investigate The Safety And Toleration Of A Single Dose Of PF-04418948 In Healthy Volunteers

NCT ID: NCT01002963

Last Updated: 2010-10-25

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

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-02-28

Brief Summary

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The purpose of this study is to investigate safety and toleration of single oral doses as well as the time course of PF-04418948 concentration in the blood following dosing by oral solution.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-04418948 30 mg

Group Type EXPERIMENTAL

PF-04418948

Intervention Type DRUG

solution, 30 mg, single

PF-04418948 100 mg

Group Type EXPERIMENTAL

PF-04418948

Intervention Type DRUG

solution, 100 mg, single

PF-04418948 300 mg

Group Type EXPERIMENTAL

PF-04418948

Intervention Type DRUG

solution, 300 mg, single

PF-04418948 1000 mg

Group Type EXPERIMENTAL

PF-04418948

Intervention Type DRUG

solution, 1000 mg, single

PF-04418948 3000 mg

Group Type EXPERIMENTAL

PF-04418948

Intervention Type DRUG

solution, 3000 mg, single

PF-04418948 4500 mg

Group Type EXPERIMENTAL

PF-04418948

Intervention Type DRUG

solution, 4500 mg, single

PF-04418948 6000 mg

Group Type EXPERIMENTAL

PF-04418948

Intervention Type DRUG

solution, 6000 mg, single

Interventions

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PF-04418948

solution, 30 mg, single

Intervention Type DRUG

PF-04418948

solution, 100 mg, single

Intervention Type DRUG

PF-04418948

solution, 300 mg, single

Intervention Type DRUG

PF-04418948

solution, 1000 mg, single

Intervention Type DRUG

PF-04418948

solution, 3000 mg, single

Intervention Type DRUG

PF-04418948

solution, 4500 mg, single

Intervention Type DRUG

PF-04418948

solution, 6000 mg, single

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects between the ages of 18 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs).

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).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 21 drinks/week for males.
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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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Brussels, , Belgium

Site Status

Countries

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Belgium

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0631001&StudyName=A%20Study%20To%20Investigate%20The%20Safety%20And%20Toleration%20Of%20A%20Single%20Dose%20Of%20PF-04418948%20In%20Healthy%20Volunteers

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

Other Identifiers

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B0631001

Identifier Type: -

Identifier Source: org_study_id