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A Study to Investigate the Effect of PH-797804 on QTc Interval

NCT ID: NCT01862887

Last Updated: 2013-08-15

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-08-31

Brief Summary

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The purpose of this study is to investigate the effect of PH-797804 following dosing of a 24 mg oral tablet on the QTc interval

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

DOUBLE

Participants Investigators

Study Groups

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PH-797804

Subjects will receive a single 24 mg dose in the fed state

Group Type EXPERIMENTAL

PH-797804

Intervention Type DRUG

Tablet, 24 mg, single dose

Moxifloxacin

Subjects will receive a single 400 mg dose in the fed state

Group Type EXPERIMENTAL

Moxifloxacin

Intervention Type DRUG

Tablet, 400 mg, single dose

Placebo

Subjects will receive a single placebo dose

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Tablet, PH-797804 matched placebo, single dose

Interventions

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PH-797804

Tablet, 24 mg, single dose

Intervention Type DRUG

Moxifloxacin

Tablet, 400 mg, single dose

Intervention Type DRUG

Placebo

Tablet, PH-797804 matched placebo, 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

Locations

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Pfizer Investigational Site

New Haven, Connecticut, 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=A6631035&StudyName=A%20Study%20to%20Investigate%20the%20Effect%20of%20PH-797804%20on%20QTc%20Interval

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

Other Identifiers

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A6631035

Identifier Type: -

Identifier Source: org_study_id