Phase 1 N=44 Randomized Triple-blind Basic Science

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

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT02785770 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2018

Primary outcome: Primary: 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 — 404.09; 408.92; 404.38 Millisecond (Msec) — p=0.8195

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: PF-04447943 (Drug); Placebo (Drug); Moxifloxacin (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Oct 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	404.09; 408.92; 404.38	0.8195
PRIMARY Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 1 Hour Post-Dose	404.23; 409.14; 404.09	0.9146
PRIMARY Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 2 Hours Post-Dose	403.76; 406.78; 402.52	0.3272
PRIMARY Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 3 Hours Post-Dose	403.95; 406.69; 404.43	0.7024
PRIMARY Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 4 Hours Post-Dose	402.76; 405.94; 404.73	0.1201
PRIMARY Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 8 Hours Post-Dose	397.31; 398.55; 398.66	0.2870
PRIMARY Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 12 Hours Post-Dose	399.83; 399.38; 401.99	0.0893
PRIMARY Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 24 Hours Post-Dose	401.72; 400.28; 403.06	0.2892
SECONDARY Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for Moxifloxacin and Placebo	405.34; 404.38; 411.98; 404.09; 413.85; 402.52	0.4540
SECONDARY Time-Matched Mean Difference in Heart Rate for PF-04447943 and Placebo	60.72; 63.91; 59.44; 60.98; 64.43; 58.60	0.1600
SECONDARY Time-Matched Mean Difference in PR Interval for PF-04447943 and Placebo	171.59; 170.52; 172.24; 171.15; 169.28; 172.09	0.5760
SECONDARY Time-Matched Mean Difference in QRS Interval for PF-04447943 and Placebo	90.76; 89.28; 89.96; 90.51; 89.18; 90.37	0.2588
SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	11; 9; 8; 8; 0; 0	—
SECONDARY Number of Participants With Physical Examination Abnormalities	1; 1; 1; 2	—
SECONDARY Number of Participants With Electrocardiogram (ECG) Abnormalities	1; 3; 1; 0; 0; 0	—
SECONDARY Number of Participants With Vital Sign Abnormalities	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Laboratory Test Abnormalities	17; 12; 12; 18	—
SECONDARY Maximum Plasma Concentration (Cmax) of PF-04447943	225.8; 947.3	—
SECONDARY Time of Observed Maximum Plasma Concentration (Tmax) of PF-04447943	1.0; 1.02	—
SECONDARY Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUClast) of PF-04447943	1454; 6277	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02785770). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.