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

Pfizer logo

Pfizer

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Moxifloxacin
Drug: PF-04447943
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02785770
B0401018

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

44 participants in 4 patient groups, including a placebo group

PF-04447943 low dose
Experimental group
Description:
25 mg of PF-04447943
Treatment:
Drug: PF-04447943
PF-04447943 high dose
Experimental group
Description:
100 mg of PF-04447943
Treatment:
Drug: PF-04447943
Placebo
Placebo Comparator group
Description:
Matching placebo for PF-04447943
Treatment:
Drug: Placebo
Moxifloxacin
Active Comparator group
Description:
400 mg of moxifloxacin
Treatment:
Drug: Moxifloxacin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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