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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
44
Single oral dose of PF-04447943 administered as an extemporaneously prepared solution
Single oral dose of matching placebo for PF-04447943 administered as an extemporaneously prepared solution
Single oral dose of moxifloxacin administered as tablet
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, United States
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
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time frame: 0.5 hour post-dose
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 1 Hour Post-Dose
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time frame: 1 hour post-dose
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 2 Hours Post-Dose
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time frame: 2 hours post-dose
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 3 Hours Post-Dose
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time frame: 3 hours post-dose
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 4 Hours Post-Dose
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
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Time frame: 4 hours post-dose
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 8 Hours Post-Dose
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time frame: 8 hours post-dose
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 12 Hours Post-Dose
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time frame: 12 hours post-dose
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 24 Hours Post-Dose
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time frame: 24 hours post-dose
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for Moxifloxacin and Placebo
Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across Moxifloxacin and placebo is reported in statistical analysis.
Time frame: 0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose
Time-Matched Mean Difference in Heart Rate for PF-04447943 and Placebo
Least square mean of heart rate measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time frame: 0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose
Time-Matched Mean Difference in PR Interval for PF-04447943 and Placebo
Least square mean of PR interval measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time frame: 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
Time-Matched Mean Difference in QRS Interval for PF-04447943 and Placebo
Least square mean of QRS interval measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.
Time frame: 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state.
Time frame: Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days)
Number of Participants With Physical Examination Abnormalities
Full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. Physical examination abnormalities were judged by the investigator.
Time frame: Baseline (Pre-dose)
Number of Participants With Electrocardiogram (ECG) Abnormalities
Criteria for ECG abnormalities: maximum QTc corrected for heart rate using Bazett's formula (QTcB) and QTcF interval (450 to less than \[\<\] 480 msec, 480 to \<500 msec, greater than or equal to \[\>=\] 500 msec; increase from baseline \[IFB\] \>=30 msec and \<60 msec, IFB \>=60 msec). Baseline was defined as the average of the means obtained from the 3 sets of triplicate measurements taken at -1, -0.5 and 0 hours pre-dose on Day 1 within each intervention period.
Time frame: Baseline up to 24 hours post-dose
Number of Participants With Vital Sign Abnormalities
Criteria for vital sign abnormalities: supine and standing pulse rate \<40 bpm or greater than (\>) 120 bpm, supine and standing systolic blood pressure (SBP) \<90 millimeter of mercury (mmHg), supine and standing diastolic blood pressure (DBP) \<50 mmHg, maximum (max.) increase from baseline (IFB) and decrease from baseline (DFB) in supine and standing SBP of \>=30 mmHg, maximum IFB and DFB in supine and Standing DBP of \>=20 mmHg.
Time frame: Baseline (Pre-dose) up to 24 hours post-dose
Number of Participants With Laboratory Test Abnormalities
Hemoglobin(Hgb), hematocrit, red blood cell(RBC)\<0.8\*lower limit of normal(LLN), mean corpuscular(MC) Hgb, MC volume \<0.9\*LLN, \>1.1\*upper limit of normal(ULN), platelet\<0.5\*LLN,\>1.75\*ULN, lymphocyte, neutrophil\<0.8\*LLN, \>1.2\*ULN, basophil, eosinophil, monocyte\>1.2\*ULN, white blood cell(WBC)\<0.6\*LLN,\>1.5\*ULN, reticulocytes\<0.5\*LLN,\>1.5\*ULN; bilirubin\>1.5\*ULN, aspartate aminotransferase(AT), alanine AT, alkaline phosphatase\>3.0\*ULN, protein, albumin\<0.8\*LLN,\>1.2\*ULN; blood urea nitrogen, creatinine\>1.3\*ULN, uric acid\>1.2\*ULN; sodium\<0.95\*LLN,\>1.05\*ULN, potassium, chloride, calcium, bicarbonate\<0.9\*LLN,\>1.1\*ULN; glucose\<0.6\*LLN, \>1.5\*ULN, HbA1c\>1.3\*ULN, creatinine kinase\>2\*ULN; urine-specific gravity\<1.003,\>1.030, pH\<4.5,\>8, WBC, RBC\>=20, bacteria\>20, urobilinogen, glucose, ketone, protein, Hgb, nitrite, leukocyte esterase, bilirubin\>=1; thyroid stimulating hormone\<0.8\*LLN,\>1.2\*ULN; cholesterol, triglycerides\>1.3\*ULN, high density lipoprotein cholesterol(DL-C) \<0.8\*LLN, low DL-C\>1.2\*ULN.
Time frame: Baseline (Pre-dose) up to 24 hours post-dose
Maximum Plasma Concentration (Cmax) of PF-04447943
Time frame: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
Time of Observed Maximum Plasma Concentration (Tmax) of PF-04447943
Time frame: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUClast) of PF-04447943
Area under the plasma concentration-time from time zero to time of last measurable concentration. Observed using the linear/log trapezoidal method.
Time frame: Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose