The purposes of this study are: * To see how the new medicine (PF-06954522) under study behave. And if there are any important side effects. A side effect is a reaction (expected or unexpected) to a medicine or treatment you take. The study will see how people feel after taking single increasing amount of the medicine by mouth. * To measure the amount of study medicine in your blood after the medicine is taken by mouth. This study is seeking for participants who: * are females of 18 to 65 years old and are not able to give birth to a child. * are males of 18 to 65 years old. * have body mass index of 16 to 31 kilograms per meter squared. * have a total body weight of more than 50 kilograms (110 pounds). Participants will be chosen by chance, like drawing names out of a hat to receive either: * study medicine (PF-06954522) * or placebo (a pill that has no medicine in it). Participants may receive up to 4 amounts of study medicine and up to 2 amounts of placebo. The time frame of the study is approximately up to 36 days for each group and participants will stay at CRU for 20 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
26
PF-06954522 will be administered as oral suspensions as escalating single doses to be determined.
Placebo will be administered as oral suspensions as escalating single doses to be determined.
Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, United States
Cohort 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AEs) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. Serious AE (SAE) was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect. AEs included SAEs and non-SAEs.
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
Cohort 2: Number of Participants With TEAEs
An AEs was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. SAE was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect. AEs included SAEs and non-SAEs.
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
Cohort 3: Number of Participants With TEAEs
An AEs was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. SAE was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect. AEs included SAEs and non-SAEs.
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
Cohort 1: Number of Participants With Hematology Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned hematology laboratory tests included: hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
Cohort 2: Number of Participants With Hematology Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned hematology laboratory tests included: hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
Cohort 3: Number of Participants With Hematology Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned hematology laboratory tests included: hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
Cohort 1: Number of Participants With Clinical Chemistry Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned chemistry laboratory tests included: blood urea nitrogen, creatinine, cystatin C, estimated glomerular filtration rate, glucose (fasting), calcium, sodium, potassium. chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl transferase, alkaline phosphatase, creatine kinase, uric acid, albumin and total protein. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
Cohort 2: Number of Participants With Clinical Chemistry Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned chemistry laboratory tests included: blood urea nitrogen, creatinine, cystatin C, estimated glomerular filtration rate, glucose (fasting), calcium, sodium, potassium. chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl transferase, alkaline phosphatase, creatine kinase, uric acid, albumin and total protein. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
Cohort 3: Number of Participants With Clinical Chemistry Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned chemistry laboratory tests included: blood urea nitrogen, creatinine, cystatin C, estimated glomerular filtration rate, glucose (fasting), calcium, sodium, potassium. chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl transferase, alkaline phosphatase, creatine kinase, uric acid, albumin and total protein. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
Cohort 1: Number of Participants With Urinalysis Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned urinalysis laboratory tests included: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen and urine bilirubin. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
Cohort 2: Number of Participants With Urinalysis Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned urinalysis laboratory tests included: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen and urine bilirubin. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
Cohort 3: Number of Participants With Urinalysis Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Planned urinalysis laboratory tests included: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen and urine bilirubin. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
Cohort 1: Number of Participants According to Categorization of Vital Signs Abnormalities Data
Vital signs parameters were summarized according to pre-specified categorization of data: supine systolic blood pressure: Value less than (\<) 90 millimeter of mercury (mmHg), increase or decrease from baseline \>= 30mmHg, supine diastolic blood pressure: value \<50 mmHg, increase or decrease from baseline \>= 20mmHg and supine pulse rate: Value \< 40 beats per minute bpm or \> 120bpm.
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
Cohort 2: Number of Participants According to Categorization of Vital Signs Abnormalities Data
Vital signs parameters were summarized according to pre-specified categorization of data: supine systolic blood pressure: Value less than (\<) 90 millimeter of mercury (mmHg), increase or decrease from baseline \>= 30mmHg, supine diastolic blood pressure: value \<50 mmHg, increase or decrease from baseline \>= 20mmHg and supine pulse rate: Value \< 40 beats per minute bpm or \> 120bpm.
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
Cohort 3: Number of Participants According to Categorization of Vital Signs Abnormalities Data
Vital signs parameters were summarized according to pre-specified categorization of data: supine systolic blood pressure: Value less than (\<) 90 millimeter of mercury (mmHg), increase or decrease from baseline \>= 30mmHg, supine diastolic blood pressure: value \<50 mmHg and increase or decrease from baseline \>= 20mmHg.
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
Cohort 1: Number of Participants According to Categorization of Electrocardiogram (ECG) Abnormalities Parameters
Pre-specified ECG abnormalities criteria : PR interval millisecond (msec), value \>=300, baseline \> 200 and percentage (%) change \>=25%, baseline \<=200 and percentage change \>=50%; QRS duration (msec): value \>=140, % change\>= 50%; corrected QT interval using Fridericia's formula (QTcF) (msec): 450 \< value \<= 480, 480\<= value \<500, value \>=500, 30\<= change \<60 and change \> 60.
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
Cohort 2: Number of Participants According to Categorization of ECG Abnormalities Parameters
Pre-specified ECG abnormalities criteria : PR interval millisecond (msec), value \>=300, baseline \> 200 and percentage (%) change \>=25%, baseline \<=200 and percentage change \>=50%; QRS duration (msec): value \>=140, % change\>= 50%; corrected QT interval using Fridericia's formula (QTcF) (msec): 450 \< value \<= 480, 480\<= value \<500, value \>=500, 30\<= change \<60 and change \> 60.
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)
Cohort 3: Number of Participants According to Categorization of ECG Abnormalities Parameters
Pre-specified ECG abnormalities criteria : PR interval millisecond (msec), value \>=300, baseline \> 200 and percentage (%) change \>=25%, baseline \<=200 and percentage change \>=50%; QRS duration (msec): value \>=140, % change\>= 50%; corrected QT interval using Fridericia's formula (QTcF) (msec): 450 \< value \<= 480, 480\<= value \<500, value \>=500, 30\<= change \<60 and change \> 60.
Time frame: From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)
Cohort 1: Area Under the Plasma Concentration-Time Profile From Time Zero (0) to Time of Last Quantifiable Concentration (AUClast) of PF-06954522
AUClast was determined by using linear/log trapezoidal method.
Time frame: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 2: AUClast of PF-06954522
AUClast was determined by using linear/log trapezoidal method.
Time frame: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 1: Maximum Observed Concentration (Cmax) of PF-06954522
Cmax of PF-06954522 was reported in this outcome measure.
Time frame: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 2: Cmax of PF-06954522
Cmax of PF-06954522 was reported in this outcome measure.
Time frame: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 1: Time to Maximum Observed Concentration (Tmax) of PF-06954522
Tmax of PF-06954522 was reported in this outcome measure.
Time frame: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 2: Tmax of PF-06954522
Tmax of PF-06954522 was reported in this outcome measure.
Time frame: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 1: Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf) of PF-06954522
Area under the plasma concentration-time profile from time 0 extrapolated to infinite time. It was determined by AUClast +(Clast\*/kel), where Clast is the predicted plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis.
Time frame: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
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Cohort 2: AUCinf of PF-06954522
Area under the plasma concentration-time profile from time 0 extrapolated to infinite time. It was determined by AUClast +(Clast\*/kel), where Clast is the predicted plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis.
Time frame: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 1: Terminal Half-Life (t1/2) of PF-06954522
t1/2 was determined by Loge (2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Time frame: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1
Cohort 2: t1/2 of PF-06954522
t1/2was determined by Loge (2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Time frame: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1