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

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

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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