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A Pharmacokinetic Study of Three Different Particle Sizes of PH-797804

NCT ID: NCT01924650

Last Updated: 2013-12-20

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

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-06-30

Brief Summary

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The purpose of this study is to investigate the effects of varying particle size on the pharmacokinetics of PH-797804

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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PH-797804 PARTICLE SIZE 9-11UM

Group Type EXPERIMENTAL

PH-797804

Intervention Type DRUG

Tablet, 6 mg, single dose

PH-797804 PARTICLE SIZE 9-11UM WITH SLS

Group Type EXPERIMENTAL

PH-797804

Intervention Type DRUG

Tablet, 6 mg, single dose

PH-797804 PARTICLE SIZE <= 20UM

Group Type EXPERIMENTAL

PH-797804

Intervention Type DRUG

Tablet, 6 mg, single dose

PH-797804 PARTICLE SIZE <= 20UM WITH SLS

Group Type EXPERIMENTAL

PH-797804

Intervention Type DRUG

Tablet, 6 mg, single dose

PH-797804 PARTICLE SIZE <= 5UM

Group Type EXPERIMENTAL

PH-797804

Intervention Type DRUG

Tablet, 6 mg, single dose

PH-797804 PARTICLE SIZE <= 5UM WITH SLS

Group Type EXPERIMENTAL

PH-797804

Intervention Type DRUG

Tablet, 6 mg, single dose

Interventions

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PH-797804

Tablet, 6 mg, single dose

Intervention Type DRUG

PH-797804

Tablet, 6 mg, single dose

Intervention Type DRUG

PH-797804

Tablet, 6 mg, single dose

Intervention Type DRUG

PH-797804

Tablet, 6 mg, single dose

Intervention Type DRUG

PH-797804

Tablet, 6 mg, single dose

Intervention Type DRUG

PH-797804

Tablet, 6 mg, single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects and/or healthy female subjects of non-child bearing potential 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 measurements, 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).

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 14 drinks/week for males.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

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

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6631040&StudyName=A%20Pharmacokinetic%20Study%20of%20Three%20Different%20Particle%20Sizes%20of%20PH-797804

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

Other Identifiers

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A6631040

Identifier Type: -

Identifier Source: org_study_id