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A Study To Evaluate The Effect Of PF-04447943 On Qtc Interval In Healthy Adult Subjects

NCT ID: NCT02785770

Last Updated: 2018-12-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-29

Study Completion Date

2016-10-20

Brief Summary

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This is a study designed to ascertain the effect of PF-04447943 on QT interval in healthy adult subjects. This is conducted as part of standard drug development.

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

TRIPLE

Participants Caregivers Investigators

Study Groups

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PF-04447943 low dose

25 mg of PF-04447943

Group Type EXPERIMENTAL

PF-04447943

Intervention Type DRUG

Single oral dose of PF-04447943 administered as an extemporaneously prepared solution

PF-04447943 high dose

100 mg of PF-04447943

Group Type EXPERIMENTAL

PF-04447943

Intervention Type DRUG

Single oral dose of PF-04447943 administered as an extemporaneously prepared solution

Placebo

Matching placebo for PF-04447943

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single oral dose of matching placebo for PF-04447943 administered as an extemporaneously prepared solution

Moxifloxacin

400 mg of moxifloxacin

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

Single oral dose of moxifloxacin administered as tablet

Interventions

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PF-04447943

Single oral dose of PF-04447943 administered as an extemporaneously prepared solution

Intervention Type DRUG

Placebo

Single oral dose of matching placebo for PF-04447943 administered as an extemporaneously prepared solution

Intervention Type DRUG

Moxifloxacin

Single oral dose of moxifloxacin administered as tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy female subjects of non childbearing potential and/or healthy male subjects, between the ages of 18 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg.

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 the time of dosing).
* History of cerebrovascular accident, transient ischemic attack (TIA), or traumatic brain injury.
* History of seizures or history or physical examination findings (eg localizing signs on neurologic examination) suggestive of structural central nervous system (CNS) abnormalities which may place patient at increased risk of seizures.
* History of orthostatic blood pressure changes or clinically significant orthostatic symptoms.
* Self reported history or risk factors for QT prolongation or torsades de pointes (eg, organic heart disease, congestive heart failure, hypokalemia, hypomagnesaemia, congenital long QT syndrome, myocardial ischemia or infarction), congenital deafness, family history of sudden death, and family history of long QT syndrome.
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 New Haven Clinical Research Unit

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=B0401018&StudyName=A+Phase+1%2C+Single-dose%2C+Randomized%2C+4-treatment%2C+4-period+Crossover%2C+Placebo-+And+Positive-controlled%2C+Double-blind+%28open-label+For+Positive+Control%29%2C+Sponsor-open+Study+To+Determine+The+Effect+Of+Pf-04447943+On+Qtc+Interval+In+Healthy+Adult+Subjects

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Other Identifiers

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B0401018

Identifier Type: -

Identifier Source: org_study_id