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

Last updated on May 10, 2018

FOR MORE INFORMATION
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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A Study To Evaluate The Effect Of PF-04447943 On Qtc Interval In Healthy Adult Subjects
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: PF-04447943
    Single oral dose of PF-04447943 administered as an extemporaneously prepared solution
  • Device: 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
  • 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: Device: Placebo
  • Active Comparator: Moxifloxacin
    400 mg of moxifloxacin
    Intervention: Drug: Moxifloxacin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
October 2016
October 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02785770
B0401018
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2016

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 thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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