Clinical trial NCT02785770: A Study To Evaluate The Effect Of PF-04447943 On Qtc Interval In Healthy Adult Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-05-30
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 0.5 Hour Post-Dose
timeFrame: 0.5 hour post-dose
measure: Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 1 Hour Post-Dose
timeFrame: 1 hour post-dose
measure: Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 2 Hours Post-Dose
timeFrame: 2 hours post-dose
measure: Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 3 Hours Post-Dose
timeFrame: 3 hours post-dose
measure: Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 4 Hours Post-Dose
timeFrame: 4 hours post-dose
measure: Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 8 Hours Post-Dose
timeFrame: 8 hours post-dose
measure: Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 12 Hours Post-Dose
timeFrame: 12 hours post-dose
measure: Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 24 Hours Post-Dose
timeFrame: 24 hours post-dose
Secondary outcomes:
measure: Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for Moxifloxacin and Placebo
timeFrame: 0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose
measure: Time-Matched Mean Difference in Heart Rate for PF-04447943 and Placebo
timeFrame: 0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose
measure: Time-Matched Mean Difference in PR Interval for PF-04447943 and Placebo
timeFrame: 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
measure: Time-Matched Mean Difference in QRS Interval for PF-04447943 and Placebo
timeFrame: 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days)
measure: Number of Participants With Physical Examination Abnormalities
timeFrame: Baseline (Pre-dose)
measure: Number of Participants With Electrocardiogram (ECG) Abnormalities
timeFrame: Baseline up to 24 hours post-dose
measure: Number of Participants With Vital Sign Abnormalities
timeFrame: Baseline (Pre-dose) up to 24 hours post-dose
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: Baseline (Pre-dose) up to 24 hours post-dose
measure: Maximum Plasma Concentration (Cmax) of PF-04447943
timeFrame: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
measure: Time of Observed Maximum Plasma Concentration (Tmax) of PF-04447943
timeFrame: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUClast) of PF-04447943
timeFrame: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer New Haven Clinical Research Unit
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: