Overview

This trial has been completed.

Condition healthy
Treatments pf-04447943, placebo, moxifloxacin
Phase phase 1
Sponsor Pfizer
Start date June 2016
End date October 2016
Trial size 44 participants
Trial identifier NCT02785770, B0401018

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose basic science
Arm
(Experimental)
25 mg of PF-04447943
pf-04447943
Single oral dose of PF-04447943 administered as an extemporaneously prepared solution
(Experimental)
100 mg of PF-04447943
pf-04447943
Single oral dose of PF-04447943 administered as an extemporaneously prepared solution
(Placebo Comparator)
Matching placebo for PF-04447943
placebo
Single oral dose of matching placebo for PF-04447943 administered as an extemporaneously prepared solution
(Active Comparator)
400 mg of moxifloxacin
moxifloxacin
Single oral dose of moxifloxacin administered as tablet

Primary Outcomes

Measure
Time matched mean differences in QTc interval using Fridericia's correction method (QTcF), or other correction method if warranted, between PF 04447943 and placebo at each post dose time point
time frame: -1, -0.5, 0, 0.5, 1, 2, 3, 4, 8, 12, 24 hours post dose

Secondary Outcomes

Measure
Time matched mean differences in QTcF of moxifloxacin and placebo at historical moxifloxacin median Tmax of 3 hours
time frame: -1, -0.5, 0, 0.5, 1, 2, 3, 4, 8, 12, 24 hours post dose
Time matched mean differences in heart rate between PF-04447943 and placebo
time frame: -1, -0.5, 0, 0.5, 1, 2, 3, 4, 8, 12, 24 hours post dose
Number of Participants With Adverse Events (AEs)
time frame: 0-24 hours post dose
Number of Participants With Vital Signs Findings (Including Bood Pressure and Pulse Rate) of Potential Clinical Importance
time frame: 0-24 hours post dose
Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance
time frame: 0-24 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-04447943
time frame: 0, 0.5, 1, 2, 3, 4, 8, 12, 24 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-04447943
time frame: 0, 0.5, 1, 2, 3, 4, 8, 12, 24 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-04447943
time frame: 0, 0.5, 1, 2, 3, 4, 8, 12, 24 hours post dose
Time matched mean differences in PR intervals between PF-04447943 and placebo
time frame: -1, -0.5, 0, 0.5, 1, 2, 3, 4, 8, 12, 24 hours post dose
Time matched mean differences in QRS intervals between PF-04447943 and placebo
time frame: -1, -0.5, 0, 0.5, 1, 2, 3, 4, 8, 12, 24 hours post dose

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Pfizer.