The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple repeat oral doses of PF-06372865 in healthy adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
19
Placebo
PF-06372865
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, United States
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Treatment-related AEs are any untoward medical occurrences attributed to study drug in a participant who received study drug. A serious adverse events (SAE) is 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. Treatment-emergent are events between first dose of study drug and up to 28-35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to study drug is assessed by the investigator. Participants with multiple occurrences of an AE within a category are counted once within the category.
Time frame: Baseline up to 28-35 days after last dose of study medication
Change From Baseline in Vital Signs
Measurement of systolic and diastolic blood pressure and pulse rate
Time frame: 0, 1, 2, 4, 8, and 12 hours post-dose on Days 1 and 21; also 0 and 2 hours post-dose on Days 4, 8, 11, 14, and 17
Change From Baseline in Electrocardiogram (ECG) Parameters
Measurement of the following ECG parameters: QT interval, QTcF, PR interval, RR interval, QRS interval, and heart rate.
Time frame: 0, 1, 2, 4, 8, and 12 hours post-dose on Days 1 and 21; also 0 and 2 hours post-dose on Days 4, 8, 11, 14, and 17
Number of Participants With Clinical Laboratory Abnormalities
Lab tests include: 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, folate); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity \[pH\], glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy); other (follicle stimulating hormone, urine drug screening, hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, human immunodeficiency virus).
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Time frame: Baseline up to 7-10 days after last dose of study medication
Maximum Observed Plasma Concentration (Cmax) for PF-06372865 on Day 1
Maximum observed plasma concentration
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06372865 on Day 1
Time to reach maximum observed plasma concentration
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for PF-06372865 on Day 1
Area under the concentration curve from time 0 to end of the dosing interval. The dosing interval is 12 hours.
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose
Maximum Observed Plasma Concentration (Cmax) for PF-06372865 on Day 21
Maximum observed plasma concentration
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06372865 on Day 21
Time to reach maximum observed plasma concentration
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for PF-06372865 on Day 21
Area under the concentration curve from time 0 to end of the dosing interval. The dosing interval is 12 hours.
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose
Plasma Half-Life (t1/2)
Time for the plasma concentration to decrease by one half.
Time frame: 0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Day 21