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

Last updated on November 10, 2019

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Study Location
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
Contact
1-800-254-6398
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02785770
Pfizer
Completed
A Study To Evaluate The Effect Of PF-04447943 On Qtc Interval In Healthy Adult Subjects

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Descriptive Information
Brief Title  ICMJE A Study To Evaluate The Effect Of PF-04447943 On Qtc Interval In Healthy Adult Subjects
Official Title  ICMJE A Phase 1, Single-dose, Randomized, 4-treatment, 4-period Crossover, Placebo- And Positive-controlled, Double-blind (Open-label For Positive Control), Sponsor-open Study To Determine The Effect Of PF-04447943 On Qtc Interval In Healthy Adult Subjects
Brief SummaryThis 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 DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-04447943
    Single oral dose of PF-04447943 administered as an extemporaneously prepared solution
  • Drug: Placebo
    Single oral dose of matching placebo for PF-04447943 administered as an extemporaneously prepared solution
  • Drug: Moxifloxacin
    Single oral dose of moxifloxacin administered as tablet
Study Arms  ICMJE
  • Experimental: PF-04447943 low dose
    25 mg of PF-04447943
    Intervention: Drug: PF-04447943
  • Experimental: PF-04447943 high dose
    100 mg of PF-04447943
    Intervention: Drug: PF-04447943
  • Placebo Comparator: Placebo
    Matching placebo for PF-04447943
    Intervention: Drug: Placebo
  • Active Comparator: Moxifloxacin
    400 mg of moxifloxacin
    Intervention: Drug: Moxifloxacin
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 25, 2016)
44
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 20, 2016
Actual Primary Completion DateOctober 20, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02785770
Other Study ID Numbers  ICMJE B0401018
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

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