The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of PF-06852231 after first-time administration to healthy adult subjects. The safety, tolerability, and pharmacokinetics of an active metabolite (PF-06892787) will also be evaluated in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
17
Treatment with placebo
Treatment with PF-06852231
Pfizer Clinical Research Unit
Brussels, Belgium
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Treatment-related AE are any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Y days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to study drug is assessed either yes or no by the investigator. Participants with multiple occurrences of an AE within a category are counted once within the category.
Time frame: Baseline up to 14 days after last dose of study medication
Number of Participants With Laboratory Abnormalities
Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid albumin, total protein); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity \[pH\], glucose, protein, blood, ketones, microscopy\[if urine tested positive for blood or protein\]).
Time frame: Baseline up to 14 days after last dose of study medication
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, pulse rate, and body temperature.
Time frame: 0, 1, 2, 4, 8, 12, 24, 48, 72 hours(h) post-dose
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings
Absolute values and changes from baseline for ECG parameters
Time frame: 0, 1, 2, 4, 8, 12, 24, 48, 72 h post-dose
Abnormal rhythms as observed continuous cardiac telemetry
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Cardiac rhythms measured by continuous cardiac monitoring
Time frame: 8 h post-dose
Maximum Observed Plasma Concentration (Cmax) for PF-06852231
Maximum Observed Plasma Concentration (Cmax) for PF-06852231
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 h post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06852231
Time to Reach Maximum Observed PF-06852231 Plasma Concentration (Tmax)
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 h post-dose
Area Under the Curve From Time Zero to Time of Last Measurable Plasma Concentration (AUClast) for PF-06852231
AUClast = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to time of last measurable plasma concentration.
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 h post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-06852231
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 h post-dose
Plasma Decay Half-Life (t1/2) of PF-06852231
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 h post-dose
Maximum Observed Plasma Concentration (Cmax) for PF-06892787 (metabolite of PF-06852231)
Maximum Observed Plasma Concentration (Cmax) for PF-06892787
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 h post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06892787 (metabolite of PF-06852231)
Time to Reach Maximum Observed PF-06892787 Plasma Concentration (Tmax)
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 h post-dose
Area Under the Curve From Time Zero to Time of Last Measurable Plasma Concentration (AUClast) for PF-06892787 (metabolite of PF-06852231)
AUClast = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to time of last measurable plasma concentration.
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 h post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-06892787 (metabolite of PF-06852231)
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 h post-dose
Plasma Decay Half-Life (t1/2) of PF-06892787 (metabolite of PF-06852231)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 h post-dose