Hemophilia A
Conditions
Keywords
Phase 1, Safety, Pharmacokinetic, Pharmacodynamic
Brief summary
This study hypothesizes that the study drug, PF-05280602 (at the selected doses) will be safe to administer to subjects with severe Hemophilia A or B with or without inhibitors and will demonstrate evidence of hemostatic activity. This is supported by the preclinical findings in hemophilic animal models.
Interventions
BIOLOGICALPF-05280602
0.5 micrograms per kilogram of PF-05280602, IV infusion, single dose
Sponsors
Catalyst Biosciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
The was an ascending dose trial with one open label treatment, intervention model was sequential dose escalation.
Eligibility
Sex/Gender
MALE
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Male subjects 18 to \<65 years old with severe hemophilia A or B with or without inhibitors to FVIII or FIX. * Subjects is willing and able to comply with the mandatory washout periods prior to screening and prior to dosing and through 48 hours post dosing. At screening this includes a washout of FIX for 96 hours and FVIII for 72 houts. At dosing this includes a washout of FIX for 96 hours and FVIII and other hemostatic agents for 72 hours through 48 hours post dosing. * Subjects must agree and commit to using a a highly effective method of birth control from the time of screening through four weeks after study drug administration.
Exclusion criteria
* Presence of a bleeding disorder in addition to hemophilia A or B. * Regular, concomitant therapy with immunomodulating drugs (eg, intravenous immunoglobulin, and routine systemic corticosteroids). * History of coronary artery disease, thrombolic disease or diagnosis of prothrombic disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity) | Baseline through Day 60 | Assays for the determination of a positive immune response was performed. An antibody immune response was defined as a confirmed post-treatment positive ELISA result in combination with a negative baseline sample ELISA result. Positive antibody immune responses to PF-05280602 by ELISA was evaluated for cross reactivity to NovoSeven RT and to Factor VII. |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline, Day 2, Day 3, and Day 15 | Supine blood pressure (BP) was measured with the participant's arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg) after 5 minutes of rest. The same arm (preferably the dominant arm) was to be used throughout the study. |
| Change From Baseline in Body Weight | Baseline, Day 2, Day 3, and Day 15 | — |
| Change From Baseline in Body Temperature | Baseline, Day 2, Day 3, and Day 15 | Body temperature was measured by mouth (oral) or ear (tympanic). A temperature greater than 38.5 degree Celsius was considered a fever. |
| Change From Baseline in Respiration Rate | Baseline, Day 2, Day 3, and Day 15 | Respiration rate measured as respirations per minute (resp/min). |
| Change From Baseline in Supine Pulse Rate | Baseline, Day 2, Day 3, and Day 15 | Change from baseline is the vital sign value at Day 2, Day 3, and Day 15 minus vital sign value at baseline. |
| Number of Participants With Changes Since Previous Physical Examination | Baseline (Day 0), Day 1, Day 2, Day 3, Day 15 | Physical examinations were conducted by a physician, trained physician's assistant, or nurse practitioner. A complete physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, genitourinary, gastrointestinal, musculoskeletal, and neurological systems. The limited or abbreviated physical examination focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. |
| Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | Baseline through Day 15 | ECG findings of potential clinical concern were: PR interval greater than or equal to (\>=)300 milliseconds (msec), \>=25% increase from baseline for baseline values \>200 msec, \>=50% increase from baseline for baseline values less than or equal to (\<=)200 msec; QRS complex \>=140 msec or \>=50% increase from baseline; QTcF interval (Fridericia's correction) \>=450 msec or \>=30 msec increase from baseline. |
| Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs (Except Hemophilia AEs) | Baseline through Day 60 | An AE was any untoward medical occurrence in a participant who received study drug. 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. Treatment-emergent are events between first dose of study drug and up to Day 15 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. |
| Number of Participants With Treatment-Emergent Hemophilia AEs and Withdrawals Due to Hemophilia AEs | Baseline through Day 60 | Hemophilia AEs included spontaneous (no known contributing factor) and traumatic (known or presumed contributing factor/reason) bleeding episodes. |
| Number of Treatment-Emergent AEs and SAEs by Severity (Except Hemophilia AEs) | Baseline through Day 60 | AE severity were graded as mild, moderate, or severe. Mild severity AEs do not interfere with the participant's usual function. Moderate AEs interfere to some extent with the participant's usual function. Severe AEs interfere significantly with the participant's usual function. |
| Number of Treatment-Emergent Hemophilia AEs by Severity | Baseline through Day 60 | Mild severity AEs do not interfere with the participant's usual function. Moderate AEs interfere to some extent with the participant's usual function. Severe AEs interfere significantly with the participant's usual function. |
| Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude | Baseline through Day 15 | Troponin-T is a cardiac marker for the evaluation of possible cardiovascular injury. Troponin-T levels of potential clinical concern are values \>1.5 times the upper limit of normal (1.5X ULN) or \>=2.5X ULN. |
| Number of Participants With Treatment-Emergent Abnormal Anti-Thrombin III (ATIII) Levels by Magnitude | Baseline through Day 3 | ATIII is a protein in the blood that blocks abnormal blood clots from forming. Low levels of ATIII can cause abnormal blood clots. ATIII levels of potential clinical concern are values \<1X LLN and \>1X ULN. |
| Number of Participants With Treatment-Emergent Abnormal Tissue Factor Pathway Inhibitor (TFPI) Levels by Magnitude | Baseline through Day 3 | TFPI is a polypeptide that can regulate blood coagulation. TFPI levels of potential clinical concern are values \<1X LLN and \>1X ULN. |
| Number of Participants With Treatment-Emergent Laboratory Test Abnormalities (Normal Baseline) | Baseline through Day 15 | The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell \[RBC\] count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); chemistry (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], alkaline phosphatase, creatinine, blood urea nitrogen \[BUN\], glucose, uric acid, sodium, potassium, chloride, bicarbonate, calcium, albumin, total protein, creatine kinase); urinalysis (urine white blood cell \[WBC\], urine RBC); other (troponin T). |
| Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Baseline through Day 15 | Clinically significant findings for stopping rules are: hemoglobin \<8 grams/deciliter (g/dL) or \>20% decrease from normal baseline; WBC \>20,000 cells/mm\^3 or \<1,500 decrease with normal baseline; platelets \<100,000/mm\^3 or \>33% decrease from baseline; total bilirubin \>1.5X ULN; AST or ALT \>2.5X ULN; alkaline phosphatase \>3X ULN; creatinine \>1.5X baseline; BUN \>31.0 mg/dL; glucose \<0.6 or \>1.5X reference range; uric acid \> ULN; sodium \>150 or \<130 mEq/L; potassium \>5.5 or \<3.0 mEq/L; calcium \>11.5 or \<8.0 mg/dL; albumin \<2.0 g/L; total protein \<5.0 g/L; positive D-dimer at Day 15; PT prolonged by 3 seconds above baseline; ATIII \< LLN and \>20% decrease from baseline; troponin-T values above the reference range; fibrinogen \<0.75X LLN or \>25% decrease from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose) | — |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) |
| Terminal Elimination Half-Life (t1/2) | Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose) | t1/2 is the time measured for the plasma concentration to decrease by one half. |
| Incremental Recovery (IncRec) | Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose) | IncRec is the maximum rise in plasma concentration per administered dose. |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose) | AUCinf is area under the plasma concentration-time curve from time 0 extrapolated to infinite time. |
| Mean Residence Time (MRT) | Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose) | MRT is AUMCinf/AUCinf, where AUMC is the area under the first moment curve. |
| Volume of Distribution at Steady State (Vss) | Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose) | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. |
| Clearance (CL) | Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose) | Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose is influenced by the fraction of the dose absorbed. |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose) | — |
| Maximum Mean Decrease From Baseline in Prothrombin Time (PT) | Baseline through Day 15 | PT measures how long it takes blood to clot. Maximum mean decrease from baseline at any time point was reported. |
| Maximum Mean Decrease From Baseline in Activated Partial Thromboplastin Time (aPTT) | Baseline through Day 15 | aPTT is a blood test that characterizes blood coagulation. Maximum mean decrease from baseline at any time point was reported. |
| Maximum Mean Increase From Baseline in Thrombin Anti-Thrombin (TAT) Complexes | Baseline through Day 3 | TAT complex is a parameter of coagulation and fibrinolysis. The normal reference range of values for TAT is 1 to 4.1 mcg/L. Elevated TAT concentrations may signify predisposition to thrombosis. Maximum mean increase from baseline at any time point was reported. |
| Maximum Mean Increase From Baseline in Prothrombin Fragments 1+2 | Baseline through Day 3 | Prothrombin fragment 1+2 is a coagulation factor, released when prothrombin is cleaved by activated Factor X. Elevated plasma levels of prothrombin fragment 1+2 indicate high risk of thrombosis. Maximum mean increase from baseline at any time point was reported. |
| Maximum Mean Increase From Baseline in D-Dimers | Baseline through Day 15 | D-dimer is an indicator of fibrin formation and its subsequent lysis and is a useful biomarker representing overall activation of blood coagulation. Maximum mean increase from baseline at any time point was reported. |
| Maximum Mean Increase From Baseline in Endogenous Thrombin Potential (ETP) | Baseline through Day 3 | ETP was evaluated using a Thrombin Generation Assay (TGA), a validated automated ex-vivo assay that measures the ability of plasma to generate thrombin. Thrombin generation curves are generated and calculated using dedicated software. ETP is the area under the thrombin generation curve and represents the total amount of generated thrombin. Maximum mean increase from baseline at any time point was reported. |
| Maximum Mean Decrease From Baseline in Thrombin Generation Lag Time | Baseline through Day 3 | The lag time is defined as the time to reach one sixth of the peak height and is a measure of the initiation phase. It is equivalent to the clotting time. Maximum mean decrease from baseline at any time point was reported. |
| Maximum Mean Increase From Baseline in Peak Thrombin Generation | Baseline through Day 3 | The peak height is defined as the maximum thrombin concentration produced. Maximum mean increase from baseline at any time point was reported. |
Countries
Belgium, Hungary, Italy, New Zealand, South Africa, Turkey (Türkiye), United Kingdom, United States
Participant flow
Pre-assignment details
This was an open-label study to characterize the single dose pharmacokinetics (PK), pharmacodynamics, safety, and tolerability of 5 intravenous dose levels of PF-05280602 (0.5, 4.5, 9.0, 18.0 and 30.0 micrograms/kilogram \[mcg/kg\]).
Participants by arm
| Arm | Count |
|---|---|
| PF-05280602 0.5 mcg/kg PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | 1 |
| PF-05280602 4.5 mcg/kg PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | 6 |
| PF-05280602 9.0 mcg/kg PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | 6 |
| PF-05280602 18.0 mcg/kg PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | 6 |
| PF-05280602 30.0 mcg/kg PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | 6 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Required number in cohort dosed | 0 | 1 | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | PF-05280602 30.0 mcg/kg | Total | PF-05280602 0.5 mcg/kg | PF-05280602 4.5 mcg/kg | PF-05280602 9.0 mcg/kg | PF-05280602 18.0 mcg/kg |
|---|---|---|---|---|---|---|
| Age, Continuous | 41.0 years STANDARD_DEVIATION 15.7 | 37.2 years STANDARD_DEVIATION 13.6 | 59.0 years | 32.7 years STANDARD_DEVIATION 13.4 | 38.5 years STANDARD_DEVIATION 12.1 | 32.8 years STANDARD_DEVIATION 12.3 |
| Sex: Female, Male FEMALE | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male MALE | 6 Participants | 25 Participants | 1 Participants | 6 Participants | 6 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 1 | 5 / 6 | 5 / 6 | 3 / 6 | 3 / 6 |
| serious Total, serious adverse events | 0 / 1 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Change From Baseline in Body Temperature
Body temperature was measured by mouth (oral) or ear (tympanic). A temperature greater than 38.5 degree Celsius was considered a fever.
Time frame: Baseline, Day 2, Day 3, and Day 15
Population: The safety population included all enrolled participants who received the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Change From Baseline in Body Temperature | Baseline | 36.1 degree Celcius | — |
| PF-05280602 0.5 mcg/kg | Change From Baseline in Body Temperature | Change at Day 2 | 0.4 degree Celcius | — |
| PF-05280602 0.5 mcg/kg | Change From Baseline in Body Temperature | Change at Day 3 | 0.3 degree Celcius | — |
| PF-05280602 0.5 mcg/kg | Change From Baseline in Body Temperature | Change at Day 15 | 0.3 degree Celcius | — |
| PF-05280602 4.5 mcg/kg | Change From Baseline in Body Temperature | Baseline | 36.5 degree Celcius | Standard Deviation 0.29 |
| PF-05280602 4.5 mcg/kg | Change From Baseline in Body Temperature | Change at Day 15 | 0.1 degree Celcius | Standard Deviation 0.39 |
| PF-05280602 4.5 mcg/kg | Change From Baseline in Body Temperature | Change at Day 2 | -0.4 degree Celcius | Standard Deviation 0.62 |
| PF-05280602 4.5 mcg/kg | Change From Baseline in Body Temperature | Change at Day 3 | -0.2 degree Celcius | Standard Deviation 0.6 |
| PF-05280602 9.0 mcg/kg | Change From Baseline in Body Temperature | Change at Day 15 | 0.1 degree Celcius | Standard Deviation 0.36 |
| PF-05280602 9.0 mcg/kg | Change From Baseline in Body Temperature | Change at Day 2 | -0.1 degree Celcius | Standard Deviation 0.3 |
| PF-05280602 9.0 mcg/kg | Change From Baseline in Body Temperature | Change at Day 3 | 0.1 degree Celcius | Standard Deviation 0.15 |
| PF-05280602 9.0 mcg/kg | Change From Baseline in Body Temperature | Baseline | 36.5 degree Celcius | Standard Deviation 0.34 |
| PF-05280602 18.0 mcg/kg | Change From Baseline in Body Temperature | Baseline | 36.6 degree Celcius | Standard Deviation 0.3 |
| PF-05280602 18.0 mcg/kg | Change From Baseline in Body Temperature | Change at Day 2 | 0.1 degree Celcius | Standard Deviation 0.34 |
| PF-05280602 18.0 mcg/kg | Change From Baseline in Body Temperature | Change at Day 15 | 0.1 degree Celcius | Standard Deviation 0.24 |
| PF-05280602 18.0 mcg/kg | Change From Baseline in Body Temperature | Change at Day 3 | -0.0 degree Celcius | Standard Deviation 0.41 |
| PF-05280602 30.0 mcg/kg | Change From Baseline in Body Temperature | Change at Day 15 | 0.2 degree Celcius | Standard Deviation 0.6 |
| PF-05280602 30.0 mcg/kg | Change From Baseline in Body Temperature | Change at Day 3 | 0.2 degree Celcius | Standard Deviation 0.13 |
| PF-05280602 30.0 mcg/kg | Change From Baseline in Body Temperature | Change at Day 2 | 0.2 degree Celcius | Standard Deviation 0.29 |
| PF-05280602 30.0 mcg/kg | Change From Baseline in Body Temperature | Baseline | 36.4 degree Celcius | Standard Deviation 0.43 |
Primary
Change From Baseline in Body Weight
Time frame: Baseline, Day 2, Day 3, and Day 15
Population: The safety population included all enrolled participants who received the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Change From Baseline in Body Weight | Baseline | 72.7 kilograms (kg) | — |
| PF-05280602 0.5 mcg/kg | Change From Baseline in Body Weight | Change at Day 15 | -0.5 kilograms (kg) | — |
| PF-05280602 0.5 mcg/kg | Change From Baseline in Body Weight | Change at Day 3 | -0.8 kilograms (kg) | — |
| PF-05280602 0.5 mcg/kg | Change From Baseline in Body Weight | Change at Day 2 | -0.9 kilograms (kg) | — |
| PF-05280602 4.5 mcg/kg | Change From Baseline in Body Weight | Change at Day 15 | 0.4 kilograms (kg) | Standard Deviation 1.09 |
| PF-05280602 4.5 mcg/kg | Change From Baseline in Body Weight | Change at Day 2 | -1.0 kilograms (kg) | Standard Deviation 0.98 |
| PF-05280602 4.5 mcg/kg | Change From Baseline in Body Weight | Baseline | 75.0 kilograms (kg) | Standard Deviation 12.65 |
| PF-05280602 4.5 mcg/kg | Change From Baseline in Body Weight | Change at Day 3 | -0.6 kilograms (kg) | Standard Deviation 0.85 |
| PF-05280602 9.0 mcg/kg | Change From Baseline in Body Weight | Change at Day 2 | -0.6 kilograms (kg) | Standard Deviation 0.72 |
| PF-05280602 9.0 mcg/kg | Change From Baseline in Body Weight | Baseline | 78.7 kilograms (kg) | Standard Deviation 10.73 |
| PF-05280602 9.0 mcg/kg | Change From Baseline in Body Weight | Change at Day 15 | 0.6 kilograms (kg) | Standard Deviation 1.55 |
| PF-05280602 9.0 mcg/kg | Change From Baseline in Body Weight | Change at Day 3 | -0.5 kilograms (kg) | Standard Deviation 0.6 |
| PF-05280602 18.0 mcg/kg | Change From Baseline in Body Weight | Change at Day 3 | -0.8 kilograms (kg) | Standard Deviation 1.39 |
| PF-05280602 18.0 mcg/kg | Change From Baseline in Body Weight | Change at Day 2 | -0.8 kilograms (kg) | Standard Deviation 1.31 |
| PF-05280602 18.0 mcg/kg | Change From Baseline in Body Weight | Baseline | 78.0 kilograms (kg) | Standard Deviation 11.31 |
| PF-05280602 18.0 mcg/kg | Change From Baseline in Body Weight | Change at Day 15 | 0.6 kilograms (kg) | Standard Deviation 1.26 |
| PF-05280602 30.0 mcg/kg | Change From Baseline in Body Weight | Change at Day 15 | 0.2 kilograms (kg) | Standard Deviation 0.59 |
| PF-05280602 30.0 mcg/kg | Change From Baseline in Body Weight | Baseline | 73.4 kilograms (kg) | Standard Deviation 6.88 |
| PF-05280602 30.0 mcg/kg | Change From Baseline in Body Weight | Change at Day 2 | -0.4 kilograms (kg) | Standard Deviation 0.83 |
| PF-05280602 30.0 mcg/kg | Change From Baseline in Body Weight | Change at Day 3 | -0.3 kilograms (kg) | Standard Deviation 0.56 |
Primary
Change From Baseline in Respiration Rate
Respiration rate measured as respirations per minute (resp/min).
Time frame: Baseline, Day 2, Day 3, and Day 15
Population: The safety population included all enrolled participants who received the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Change From Baseline in Respiration Rate | Baseline | 12.0 resp/min | — |
| PF-05280602 0.5 mcg/kg | Change From Baseline in Respiration Rate | Change at Day 2 | 0.0 resp/min | — |
| PF-05280602 0.5 mcg/kg | Change From Baseline in Respiration Rate | Change at Day 3 | 0.0 resp/min | — |
| PF-05280602 0.5 mcg/kg | Change From Baseline in Respiration Rate | Change at Day 15 | 2.0 resp/min | — |
| PF-05280602 4.5 mcg/kg | Change From Baseline in Respiration Rate | Baseline | 15.0 resp/min | Standard Deviation 2.76 |
| PF-05280602 4.5 mcg/kg | Change From Baseline in Respiration Rate | Change at Day 15 | 0.7 resp/min | Standard Deviation 4.32 |
| PF-05280602 4.5 mcg/kg | Change From Baseline in Respiration Rate | Change at Day 2 | 0.5 resp/min | Standard Deviation 1.76 |
| PF-05280602 4.5 mcg/kg | Change From Baseline in Respiration Rate | Change at Day 3 | 0.2 resp/min | Standard Deviation 3.37 |
| PF-05280602 9.0 mcg/kg | Change From Baseline in Respiration Rate | Change at Day 15 | -0.2 resp/min | Standard Deviation 2.14 |
| PF-05280602 9.0 mcg/kg | Change From Baseline in Respiration Rate | Change at Day 2 | 0.3 resp/min | Standard Deviation 3.5 |
| PF-05280602 9.0 mcg/kg | Change From Baseline in Respiration Rate | Change at Day 3 | 0.3 resp/min | Standard Deviation 3.5 |
| PF-05280602 9.0 mcg/kg | Change From Baseline in Respiration Rate | Baseline | 15.2 resp/min | Standard Deviation 2.04 |
| PF-05280602 18.0 mcg/kg | Change From Baseline in Respiration Rate | Baseline | 15.7 resp/min | Standard Deviation 1.97 |
| PF-05280602 18.0 mcg/kg | Change From Baseline in Respiration Rate | Change at Day 2 | 2.2 resp/min | Standard Deviation 2.56 |
| PF-05280602 18.0 mcg/kg | Change From Baseline in Respiration Rate | Change at Day 15 | 1.2 resp/min | Standard Deviation 3.49 |
| PF-05280602 18.0 mcg/kg | Change From Baseline in Respiration Rate | Change at Day 3 | 1.7 resp/min | Standard Deviation 1.63 |
| PF-05280602 30.0 mcg/kg | Change From Baseline in Respiration Rate | Change at Day 15 | -0.3 resp/min | Standard Deviation 1.97 |
| PF-05280602 30.0 mcg/kg | Change From Baseline in Respiration Rate | Change at Day 3 | 0.2 resp/min | Standard Deviation 2.23 |
| PF-05280602 30.0 mcg/kg | Change From Baseline in Respiration Rate | Change at Day 2 | 0.5 resp/min | Standard Deviation 1.22 |
| PF-05280602 30.0 mcg/kg | Change From Baseline in Respiration Rate | Baseline | 16.0 resp/min | Standard Deviation 2.83 |
Primary
Change From Baseline in Supine Pulse Rate
Change from baseline is the vital sign value at Day 2, Day 3, and Day 15 minus vital sign value at baseline.
Time frame: Baseline, Day 2, Day 3, and Day 15
Population: The safety population included all enrolled participants who received the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Change From Baseline in Supine Pulse Rate | Change at Day 2 | 1.0 beats per minute (bpm) | — |
| PF-05280602 0.5 mcg/kg | Change From Baseline in Supine Pulse Rate | Baseline | 62.0 beats per minute (bpm) | — |
| PF-05280602 0.5 mcg/kg | Change From Baseline in Supine Pulse Rate | Change at Day 3 | 0.0 beats per minute (bpm) | — |
| PF-05280602 0.5 mcg/kg | Change From Baseline in Supine Pulse Rate | Change at Day 15 | 2.0 beats per minute (bpm) | — |
| PF-05280602 4.5 mcg/kg | Change From Baseline in Supine Pulse Rate | Change at Day 15 | 8.3 beats per minute (bpm) | Standard Deviation 12.68 |
| PF-05280602 4.5 mcg/kg | Change From Baseline in Supine Pulse Rate | Change at Day 3 | 1.3 beats per minute (bpm) | Standard Deviation 6.8 |
| PF-05280602 4.5 mcg/kg | Change From Baseline in Supine Pulse Rate | Baseline | 64.8 beats per minute (bpm) | Standard Deviation 6.21 |
| PF-05280602 4.5 mcg/kg | Change From Baseline in Supine Pulse Rate | Change at Day 2 | -1.3 beats per minute (bpm) | Standard Deviation 3.56 |
| PF-05280602 9.0 mcg/kg | Change From Baseline in Supine Pulse Rate | Change at Day 15 | 4.5 beats per minute (bpm) | Standard Deviation 12.68 |
| PF-05280602 9.0 mcg/kg | Change From Baseline in Supine Pulse Rate | Baseline | 69.3 beats per minute (bpm) | Standard Deviation 10.65 |
| PF-05280602 9.0 mcg/kg | Change From Baseline in Supine Pulse Rate | Change at Day 3 | 2.5 beats per minute (bpm) | Standard Deviation 7.89 |
| PF-05280602 9.0 mcg/kg | Change From Baseline in Supine Pulse Rate | Change at Day 2 | 3.7 beats per minute (bpm) | Standard Deviation 6.89 |
| PF-05280602 18.0 mcg/kg | Change From Baseline in Supine Pulse Rate | Baseline | 60.7 beats per minute (bpm) | Standard Deviation 10.69 |
| PF-05280602 18.0 mcg/kg | Change From Baseline in Supine Pulse Rate | Change at Day 3 | 10.7 beats per minute (bpm) | Standard Deviation 5.65 |
| PF-05280602 18.0 mcg/kg | Change From Baseline in Supine Pulse Rate | Change at Day 2 | 8.8 beats per minute (bpm) | Standard Deviation 7.88 |
| PF-05280602 18.0 mcg/kg | Change From Baseline in Supine Pulse Rate | Change at Day 15 | 10.2 beats per minute (bpm) | Standard Deviation 12.22 |
| PF-05280602 30.0 mcg/kg | Change From Baseline in Supine Pulse Rate | Change at Day 2 | 2.0 beats per minute (bpm) | Standard Deviation 5.69 |
| PF-05280602 30.0 mcg/kg | Change From Baseline in Supine Pulse Rate | Baseline | 66.5 beats per minute (bpm) | Standard Deviation 8.22 |
| PF-05280602 30.0 mcg/kg | Change From Baseline in Supine Pulse Rate | Change at Day 3 | 3.3 beats per minute (bpm) | Standard Deviation 3.56 |
| PF-05280602 30.0 mcg/kg | Change From Baseline in Supine Pulse Rate | Change at Day 15 | 3.0 beats per minute (bpm) | Standard Deviation 5.33 |
Primary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Supine blood pressure (BP) was measured with the participant's arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg) after 5 minutes of rest. The same arm (preferably the dominant arm) was to be used throughout the study.
Time frame: Baseline, Day 2, Day 3, and Day 15
Population: The safety population included all enrolled participants who received the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Change at Day 2 | 2.0 mmHg | — |
| PF-05280602 0.5 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Change at Day 3 | -3.0 mmHg | — |
| PF-05280602 0.5 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Baseline | 122.0 mmHg | — |
| PF-05280602 0.5 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Change at Day 2 | 0.0 mmHg | — |
| PF-05280602 0.5 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Baseline | 78.0 mmHg | — |
| PF-05280602 0.5 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Change at Day 15 | -9.0 mmHg | — |
| PF-05280602 0.5 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Change at Day 3 | 5.0 mmHg | — |
| PF-05280602 0.5 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Change at Day 15 | -10.0 mmHg | — |
| PF-05280602 4.5 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Baseline | 130.2 mmHg | Standard Deviation 7.14 |
| PF-05280602 4.5 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Change at Day 15 | -5.5 mmHg | Standard Deviation 12.18 |
| PF-05280602 4.5 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Change at Day 15 | -3.5 mmHg | Standard Deviation 11.41 |
| PF-05280602 4.5 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Change at Day 2 | -8.7 mmHg | Standard Deviation 8.24 |
| PF-05280602 4.5 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Change at Day 3 | -6.5 mmHg | Standard Deviation 6.57 |
| PF-05280602 4.5 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Baseline | 73.7 mmHg | Standard Deviation 6.35 |
| PF-05280602 4.5 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Change at Day 2 | -2.8 mmHg | Standard Deviation 6.43 |
| PF-05280602 4.5 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Change at Day 3 | -7.0 mmHg | Standard Deviation 6.99 |
| PF-05280602 9.0 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Change at Day 3 | 3.3 mmHg | Standard Deviation 6.56 |
| PF-05280602 9.0 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Baseline | 120.2 mmHg | Standard Deviation 25.41 |
| PF-05280602 9.0 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Change at Day 15 | 6.0 mmHg | Standard Deviation 13.11 |
| PF-05280602 9.0 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Baseline | 70.5 mmHg | Standard Deviation 10.97 |
| PF-05280602 9.0 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Change at Day 3 | 2.2 mmHg | Standard Deviation 19.3 |
| PF-05280602 9.0 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Change at Day 15 | 4.7 mmHg | Standard Deviation 18 |
| PF-05280602 9.0 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Change at Day 2 | -0.2 mmHg | Standard Deviation 14.41 |
| PF-05280602 9.0 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Change at Day 2 | 2.7 mmHg | Standard Deviation 6.28 |
| PF-05280602 18.0 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Change at Day 3 | -5.5 mmHg | Standard Deviation 7.66 |
| PF-05280602 18.0 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Baseline | 124.2 mmHg | Standard Deviation 7.68 |
| PF-05280602 18.0 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Change at Day 2 | -3.0 mmHg | Standard Deviation 6.51 |
| PF-05280602 18.0 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Change at Day 15 | -4.5 mmHg | Standard Deviation 14.92 |
| PF-05280602 18.0 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Baseline | 75.8 mmHg | Standard Deviation 4.67 |
| PF-05280602 18.0 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Change at Day 2 | -0.8 mmHg | Standard Deviation 5.12 |
| PF-05280602 18.0 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Change at Day 3 | -2.2 mmHg | Standard Deviation 8.11 |
| PF-05280602 18.0 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Change at Day 15 | -4.3 mmHg | Standard Deviation 11.15 |
| PF-05280602 30.0 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Change at Day 3 | 0.0 mmHg | Standard Deviation 8.58 |
| PF-05280602 30.0 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Change at Day 15 | -4.5 mmHg | Standard Deviation 5.65 |
| PF-05280602 30.0 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Change at Day 3 | 4.3 mmHg | Standard Deviation 10.41 |
| PF-05280602 30.0 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Change at Day 2 | -1.5 mmHg | Standard Deviation 5.58 |
| PF-05280602 30.0 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Baseline | 125.5 mmHg | Standard Deviation 8.53 |
| PF-05280602 30.0 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Baseline | 77.0 mmHg | Standard Deviation 6.87 |
| PF-05280602 30.0 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Change at Day 2 | -3.3 mmHg | Standard Deviation 5.5 |
| PF-05280602 30.0 mcg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Change at Day 15 | 1.8 mmHg | Standard Deviation 11.84 |
Primary
Number of Participants With Changes Since Previous Physical Examination
Physical examinations were conducted by a physician, trained physician's assistant, or nurse practitioner. A complete physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, genitourinary, gastrointestinal, musculoskeletal, and neurological systems. The limited or abbreviated physical examination focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.
Time frame: Baseline (Day 0), Day 1, Day 2, Day 3, Day 15
Population: The safety population included all enrolled participants who received the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Number of Participants With Changes Since Previous Physical Examination | Day 3 | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Changes Since Previous Physical Examination | Day 15 | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Changes Since Previous Physical Examination | Day 1 | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Changes Since Previous Physical Examination | Baseline | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Changes Since Previous Physical Examination | Day 2 | NA participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Changes Since Previous Physical Examination | Day 3 | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Changes Since Previous Physical Examination | Day 2 | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Changes Since Previous Physical Examination | Baseline | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Changes Since Previous Physical Examination | Day 15 | 1 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Changes Since Previous Physical Examination | Day 1 | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Changes Since Previous Physical Examination | Day 2 | 1 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Changes Since Previous Physical Examination | Baseline | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Changes Since Previous Physical Examination | Day 1 | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Changes Since Previous Physical Examination | Day 3 | 1 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Changes Since Previous Physical Examination | Day 15 | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Changes Since Previous Physical Examination | Day 15 | 1 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Changes Since Previous Physical Examination | Baseline | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Changes Since Previous Physical Examination | Day 3 | 1 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Changes Since Previous Physical Examination | Day 2 | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Changes Since Previous Physical Examination | Day 1 | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Changes Since Previous Physical Examination | Day 2 | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Changes Since Previous Physical Examination | Day 3 | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Changes Since Previous Physical Examination | Baseline | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Changes Since Previous Physical Examination | Day 15 | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Changes Since Previous Physical Examination | Day 1 | 0 participants |
Primary
Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria
Clinically significant findings for stopping rules are: hemoglobin \<8 grams/deciliter (g/dL) or \>20% decrease from normal baseline; WBC \>20,000 cells/mm\^3 or \<1,500 decrease with normal baseline; platelets \<100,000/mm\^3 or \>33% decrease from baseline; total bilirubin \>1.5X ULN; AST or ALT \>2.5X ULN; alkaline phosphatase \>3X ULN; creatinine \>1.5X baseline; BUN \>31.0 mg/dL; glucose \<0.6 or \>1.5X reference range; uric acid \> ULN; sodium \>150 or \<130 mEq/L; potassium \>5.5 or \<3.0 mEq/L; calcium \>11.5 or \<8.0 mg/dL; albumin \<2.0 g/L; total protein \<5.0 g/L; positive D-dimer at Day 15; PT prolonged by 3 seconds above baseline; ATIII \< LLN and \>20% decrease from baseline; troponin-T values above the reference range; fibrinogen \<0.75X LLN or \>25% decrease from baseline.
Time frame: Baseline through Day 15
Population: The safety population included all enrolled participants who received the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Prothrombin Time | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Hemoglobin | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Uric Acid | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | ALT | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Troponin-T | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Creatinine | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Alkaline Phosphatase | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | BUN | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Platelets | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Fibrinogen | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Glucose | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Anti-Thrombin III | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | WBC | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Total Bilirubin | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Calcium | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Albumin | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Potassium | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | AST | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Sodium | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Total Protein | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | D-Dimer | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Calcium | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Total Protein | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Total Bilirubin | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Hemoglobin | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | ALT | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Prothrombin Time | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Creatinine | 1 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Sodium | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Uric Acid | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Alkaline Phosphatase | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Troponin-T | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | BUN | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | AST | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Albumin | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Fibrinogen | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | WBC | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Platelets | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Glucose | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | D-Dimer | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Potassium | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Anti-Thrombin III | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Alkaline Phosphatase | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Platelets | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | WBC | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Prothrombin Time | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Total Protein | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Potassium | 1 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Fibrinogen | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Anti-Thrombin III | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Albumin | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Total Bilirubin | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | AST | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | ALT | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Hemoglobin | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | BUN | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Creatinine | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Uric Acid | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Sodium | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Calcium | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Glucose | 1 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Troponin-T | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | D-Dimer | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Anti-Thrombin III | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Total Protein | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Uric Acid | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Total Bilirubin | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Sodium | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Albumin | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Fibrinogen | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Hemoglobin | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Calcium | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Potassium | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | AST | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Glucose | 1 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Prothrombin Time | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | WBC | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | D-Dimer | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Troponin-T | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Alkaline Phosphatase | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Platelets | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | BUN | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | ALT | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Creatinine | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | BUN | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Creatinine | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | AST | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | D-Dimer | 1 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Anti-Thrombin III | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Troponin-T | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Uric Acid | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Total Bilirubin | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Glucose | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Hemoglobin | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Prothrombin Time | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Sodium | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Albumin | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Platelets | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Potassium | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Total Protein | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Fibrinogen | 1 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | WBC | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Alkaline Phosphatase | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Calcium | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | ALT | 0 participants |
Primary
Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity)
Assays for the determination of a positive immune response was performed. An antibody immune response was defined as a confirmed post-treatment positive ELISA result in combination with a negative baseline sample ELISA result. Positive antibody immune responses to PF-05280602 by ELISA was evaluated for cross reactivity to NovoSeven RT and to Factor VII.
Time frame: Baseline through Day 60
Population: The immunogenicity parameter population included enrolled and treated participants with at least 1 post-treatment anti-PF-05280602 antibody (ADA), PF-05280602 inhibitor, or Factor VII activity level determination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity) | PF-05280602 Inhibitor | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity) | Depletion of Factor VII Activity | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity) | Factor VII Inhibitor | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity) | ADA | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity) | Factor VIIa Inhibitor | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity) | ADA | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity) | PF-05280602 Inhibitor | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity) | Factor VIIa Inhibitor | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity) | Factor VII Inhibitor | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity) | Depletion of Factor VII Activity | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity) | PF-05280602 Inhibitor | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity) | ADA | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity) | Factor VIIa Inhibitor | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity) | Factor VII Inhibitor | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity) | Depletion of Factor VII Activity | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity) | PF-05280602 Inhibitor | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity) | ADA | 1 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity) | Factor VIIa Inhibitor | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity) | Depletion of Factor VII Activity | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity) | Factor VII Inhibitor | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity) | Factor VII Inhibitor | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity) | ADA | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity) | Depletion of Factor VII Activity | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity) | Factor VIIa Inhibitor | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity) | PF-05280602 Inhibitor | 0 participants |
Primary
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
ECG findings of potential clinical concern were: PR interval greater than or equal to (\>=)300 milliseconds (msec), \>=25% increase from baseline for baseline values \>200 msec, \>=50% increase from baseline for baseline values less than or equal to (\<=)200 msec; QRS complex \>=140 msec or \>=50% increase from baseline; QTcF interval (Fridericia's correction) \>=450 msec or \>=30 msec increase from baseline.
Time frame: Baseline through Day 15
Population: The safety population included all enrolled participants who received the study drug.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval >=60 msec Increase From Baseline | 0 participants | — |
| PF-05280602 0.5 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | PR Interval >=25/50% Increase From Baseline | 0 participants | — |
| PF-05280602 0.5 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QRS Complex >=140 msec | 0 participants | — |
| PF-05280602 0.5 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval 30-<60 msec Increase From Baseline | 0 participants | — |
| PF-05280602 0.5 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QRS Complex >=50% Increase From Baseline | 0 participants | — |
| PF-05280602 0.5 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | PR Interval >=300 msec | 0 participants | — |
| PF-05280602 0.5 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval >=450 msec | 0 participants | — |
| PF-05280602 4.5 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval >=450 msec | 0 participants | — |
| PF-05280602 4.5 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | PR Interval >=300 msec | 0 participants | 7.14 |
| PF-05280602 4.5 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QRS Complex >=140 msec | 0 participants | — |
| PF-05280602 4.5 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | PR Interval >=25/50% Increase From Baseline | 0 participants | — |
| PF-05280602 4.5 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval >=60 msec Increase From Baseline | 0 participants | — |
| PF-05280602 4.5 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QRS Complex >=50% Increase From Baseline | 0 participants | — |
| PF-05280602 4.5 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval 30-<60 msec Increase From Baseline | 1 participants | — |
| PF-05280602 9.0 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval >=450 msec | 0 participants | — |
| PF-05280602 9.0 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval >=60 msec Increase From Baseline | 0 participants | — |
| PF-05280602 9.0 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QRS Complex >=140 msec | 0 participants | — |
| PF-05280602 9.0 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval 30-<60 msec Increase From Baseline | 0 participants | — |
| PF-05280602 9.0 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | PR Interval >=25/50% Increase From Baseline | 0 participants | — |
| PF-05280602 9.0 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QRS Complex >=50% Increase From Baseline | 0 participants | — |
| PF-05280602 9.0 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | PR Interval >=300 msec | 0 participants | 25.41 |
| PF-05280602 18.0 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QRS Complex >=140 msec | 0 participants | — |
| PF-05280602 18.0 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval >=60 msec Increase From Baseline | 0 participants | — |
| PF-05280602 18.0 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | PR Interval >=300 msec | 0 participants | 7.68 |
| PF-05280602 18.0 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QRS Complex >=50% Increase From Baseline | 0 participants | — |
| PF-05280602 18.0 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval 30-<60 msec Increase From Baseline | 0 participants | — |
| PF-05280602 18.0 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | PR Interval >=25/50% Increase From Baseline | 0 participants | — |
| PF-05280602 18.0 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval >=450 msec | 0 participants | — |
| PF-05280602 30.0 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval >=60 msec Increase From Baseline | 0 participants | — |
| PF-05280602 30.0 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | PR Interval >=300 msec | 0 participants | 8.53 |
| PF-05280602 30.0 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QRS Complex >=140 msec | 0 participants | — |
| PF-05280602 30.0 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | PR Interval >=25/50% Increase From Baseline | 0 participants | — |
| PF-05280602 30.0 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QRS Complex >=50% Increase From Baseline | 0 participants | — |
| PF-05280602 30.0 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval 30-<60 msec Increase From Baseline | 0 participants | — |
| PF-05280602 30.0 mcg/kg | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | QTcF Interval >=450 msec | 0 participants | — |
Primary
Number of Participants With Treatment-Emergent Abnormal Anti-Thrombin III (ATIII) Levels by Magnitude
ATIII is a protein in the blood that blocks abnormal blood clots from forming. Low levels of ATIII can cause abnormal blood clots. ATIII levels of potential clinical concern are values \<1X LLN and \>1X ULN.
Time frame: Baseline through Day 3
Population: The safety population included all enrolled participants who received the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Anti-Thrombin III (ATIII) Levels by Magnitude | <1X LLN | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Anti-Thrombin III (ATIII) Levels by Magnitude | >1X ULN | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Anti-Thrombin III (ATIII) Levels by Magnitude | <1X LLN | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Anti-Thrombin III (ATIII) Levels by Magnitude | >1X ULN | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Anti-Thrombin III (ATIII) Levels by Magnitude | <1X LLN | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Anti-Thrombin III (ATIII) Levels by Magnitude | >1X ULN | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Anti-Thrombin III (ATIII) Levels by Magnitude | >1X ULN | 1 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Anti-Thrombin III (ATIII) Levels by Magnitude | <1X LLN | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Anti-Thrombin III (ATIII) Levels by Magnitude | <1X LLN | 2 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Anti-Thrombin III (ATIII) Levels by Magnitude | >1X ULN | 0 participants |
Primary
Number of Participants With Treatment-Emergent Abnormal Tissue Factor Pathway Inhibitor (TFPI) Levels by Magnitude
TFPI is a polypeptide that can regulate blood coagulation. TFPI levels of potential clinical concern are values \<1X LLN and \>1X ULN.
Time frame: Baseline through Day 3
Population: The safety population included all enrolled participants who received the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Tissue Factor Pathway Inhibitor (TFPI) Levels by Magnitude | >1X ULN | 1 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Tissue Factor Pathway Inhibitor (TFPI) Levels by Magnitude | <1X LLN | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Tissue Factor Pathway Inhibitor (TFPI) Levels by Magnitude | <1X LLN | 1 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Tissue Factor Pathway Inhibitor (TFPI) Levels by Magnitude | >1X ULN | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Tissue Factor Pathway Inhibitor (TFPI) Levels by Magnitude | <1X LLN | 2 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Tissue Factor Pathway Inhibitor (TFPI) Levels by Magnitude | >1X ULN | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Tissue Factor Pathway Inhibitor (TFPI) Levels by Magnitude | <1X LLN | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Tissue Factor Pathway Inhibitor (TFPI) Levels by Magnitude | >1X ULN | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Tissue Factor Pathway Inhibitor (TFPI) Levels by Magnitude | <1X LLN | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Tissue Factor Pathway Inhibitor (TFPI) Levels by Magnitude | >1X ULN | 1 participants |
Primary
Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude
Troponin-T is a cardiac marker for the evaluation of possible cardiovascular injury. Troponin-T levels of potential clinical concern are values \>1.5 times the upper limit of normal (1.5X ULN) or \>=2.5X ULN.
Time frame: Baseline through Day 15
Population: The safety population included all enrolled participants who received the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude | <1X lower limit of normal (LLN) | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude | >1X ULN | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude | >1.5X ULN | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude | >=2.5X ULN | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude | <1X lower limit of normal (LLN) | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude | >=2.5X ULN | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude | >1X ULN | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude | >1.5X ULN | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude | >=2.5X ULN | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude | >1X ULN | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude | >1.5X ULN | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude | <1X lower limit of normal (LLN) | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude | <1X lower limit of normal (LLN) | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude | >1X ULN | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude | >=2.5X ULN | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude | >1.5X ULN | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude | >=2.5X ULN | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude | >1.5X ULN | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude | >1X ULN | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude | <1X lower limit of normal (LLN) | 0 participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs (Except Hemophilia AEs)
An AE was any untoward medical occurrence in a participant who received study drug. 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. Treatment-emergent are events between first dose of study drug and up to Day 15 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
Time frame: Baseline through Day 60
Population: The safety population included all enrolled participants who received the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs (Except Hemophilia AEs) | AEs | 1 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs (Except Hemophilia AEs) | Withdrawals Due to AEs | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs (Except Hemophilia AEs) | SAEs | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs (Except Hemophilia AEs) | SAEs | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs (Except Hemophilia AEs) | AEs | 4 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs (Except Hemophilia AEs) | Withdrawals Due to AEs | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs (Except Hemophilia AEs) | SAEs | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs (Except Hemophilia AEs) | AEs | 4 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs (Except Hemophilia AEs) | Withdrawals Due to AEs | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs (Except Hemophilia AEs) | AEs | 3 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs (Except Hemophilia AEs) | Withdrawals Due to AEs | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs (Except Hemophilia AEs) | SAEs | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs (Except Hemophilia AEs) | SAEs | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs (Except Hemophilia AEs) | AEs | 2 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs (Except Hemophilia AEs) | Withdrawals Due to AEs | 0 participants |
Primary
Number of Participants With Treatment-Emergent Hemophilia AEs and Withdrawals Due to Hemophilia AEs
Hemophilia AEs included spontaneous (no known contributing factor) and traumatic (known or presumed contributing factor/reason) bleeding episodes.
Time frame: Baseline through Day 60
Population: The safety population included all enrolled participants who received the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Number of Participants With Treatment-Emergent Hemophilia AEs and Withdrawals Due to Hemophilia AEs | Hemophilia AEs | 1 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Treatment-Emergent Hemophilia AEs and Withdrawals Due to Hemophilia AEs | Withdrawals Due to Hemophilia AEs | 0 participants |
| PF-05280602 0.5 mcg/kg | Number of Participants With Treatment-Emergent Hemophilia AEs and Withdrawals Due to Hemophilia AEs | Hemophilia SAEs | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Treatment-Emergent Hemophilia AEs and Withdrawals Due to Hemophilia AEs | Hemophilia SAEs | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Treatment-Emergent Hemophilia AEs and Withdrawals Due to Hemophilia AEs | Hemophilia AEs | 1 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Treatment-Emergent Hemophilia AEs and Withdrawals Due to Hemophilia AEs | Withdrawals Due to Hemophilia AEs | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Treatment-Emergent Hemophilia AEs and Withdrawals Due to Hemophilia AEs | Hemophilia SAEs | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Treatment-Emergent Hemophilia AEs and Withdrawals Due to Hemophilia AEs | Hemophilia AEs | 1 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Treatment-Emergent Hemophilia AEs and Withdrawals Due to Hemophilia AEs | Withdrawals Due to Hemophilia AEs | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Treatment-Emergent Hemophilia AEs and Withdrawals Due to Hemophilia AEs | Hemophilia AEs | 1 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Treatment-Emergent Hemophilia AEs and Withdrawals Due to Hemophilia AEs | Withdrawals Due to Hemophilia AEs | 0 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Treatment-Emergent Hemophilia AEs and Withdrawals Due to Hemophilia AEs | Hemophilia SAEs | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Treatment-Emergent Hemophilia AEs and Withdrawals Due to Hemophilia AEs | Hemophilia SAEs | 0 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Treatment-Emergent Hemophilia AEs and Withdrawals Due to Hemophilia AEs | Hemophilia AEs | 2 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Treatment-Emergent Hemophilia AEs and Withdrawals Due to Hemophilia AEs | Withdrawals Due to Hemophilia AEs | 0 participants |
Primary
Number of Participants With Treatment-Emergent Laboratory Test Abnormalities (Normal Baseline)
The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell \[RBC\] count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); chemistry (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], alkaline phosphatase, creatinine, blood urea nitrogen \[BUN\], glucose, uric acid, sodium, potassium, chloride, bicarbonate, calcium, albumin, total protein, creatine kinase); urinalysis (urine white blood cell \[WBC\], urine RBC); other (troponin T).
Time frame: Baseline through Day 15
Population: The safety population included all enrolled participants who received the study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-05280602 0.5 mcg/kg | Number of Participants With Treatment-Emergent Laboratory Test Abnormalities (Normal Baseline) | 0 participants |
| PF-05280602 4.5 mcg/kg | Number of Participants With Treatment-Emergent Laboratory Test Abnormalities (Normal Baseline) | 0 participants |
| PF-05280602 9.0 mcg/kg | Number of Participants With Treatment-Emergent Laboratory Test Abnormalities (Normal Baseline) | 2 participants |
| PF-05280602 18.0 mcg/kg | Number of Participants With Treatment-Emergent Laboratory Test Abnormalities (Normal Baseline) | 1 participants |
| PF-05280602 30.0 mcg/kg | Number of Participants With Treatment-Emergent Laboratory Test Abnormalities (Normal Baseline) | 2 participants |
Primary
Number of Treatment-Emergent AEs and SAEs by Severity (Except Hemophilia AEs)
AE severity were graded as mild, moderate, or severe. Mild severity AEs do not interfere with the participant's usual function. Moderate AEs interfere to some extent with the participant's usual function. Severe AEs interfere significantly with the participant's usual function.
Time frame: Baseline through Day 60
Population: The safety population included all enrolled participants who received the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Number of Treatment-Emergent AEs and SAEs by Severity (Except Hemophilia AEs) | Mild AEs | 2 adverse events |
| PF-05280602 0.5 mcg/kg | Number of Treatment-Emergent AEs and SAEs by Severity (Except Hemophilia AEs) | Severe AEs | 0 adverse events |
| PF-05280602 0.5 mcg/kg | Number of Treatment-Emergent AEs and SAEs by Severity (Except Hemophilia AEs) | Moderate AEs | 1 adverse events |
| PF-05280602 4.5 mcg/kg | Number of Treatment-Emergent AEs and SAEs by Severity (Except Hemophilia AEs) | Moderate AEs | 1 adverse events |
| PF-05280602 4.5 mcg/kg | Number of Treatment-Emergent AEs and SAEs by Severity (Except Hemophilia AEs) | Mild AEs | 6 adverse events |
| PF-05280602 4.5 mcg/kg | Number of Treatment-Emergent AEs and SAEs by Severity (Except Hemophilia AEs) | Severe AEs | 0 adverse events |
| PF-05280602 9.0 mcg/kg | Number of Treatment-Emergent AEs and SAEs by Severity (Except Hemophilia AEs) | Moderate AEs | 5 adverse events |
| PF-05280602 9.0 mcg/kg | Number of Treatment-Emergent AEs and SAEs by Severity (Except Hemophilia AEs) | Mild AEs | 5 adverse events |
| PF-05280602 9.0 mcg/kg | Number of Treatment-Emergent AEs and SAEs by Severity (Except Hemophilia AEs) | Severe AEs | 0 adverse events |
| PF-05280602 18.0 mcg/kg | Number of Treatment-Emergent AEs and SAEs by Severity (Except Hemophilia AEs) | Mild AEs | 7 adverse events |
| PF-05280602 18.0 mcg/kg | Number of Treatment-Emergent AEs and SAEs by Severity (Except Hemophilia AEs) | Severe AEs | 0 adverse events |
| PF-05280602 18.0 mcg/kg | Number of Treatment-Emergent AEs and SAEs by Severity (Except Hemophilia AEs) | Moderate AEs | 2 adverse events |
| PF-05280602 30.0 mcg/kg | Number of Treatment-Emergent AEs and SAEs by Severity (Except Hemophilia AEs) | Moderate AEs | 1 adverse events |
| PF-05280602 30.0 mcg/kg | Number of Treatment-Emergent AEs and SAEs by Severity (Except Hemophilia AEs) | Mild AEs | 1 adverse events |
| PF-05280602 30.0 mcg/kg | Number of Treatment-Emergent AEs and SAEs by Severity (Except Hemophilia AEs) | Severe AEs | 0 adverse events |
Primary
Number of Treatment-Emergent Hemophilia AEs by Severity
Mild severity AEs do not interfere with the participant's usual function. Moderate AEs interfere to some extent with the participant's usual function. Severe AEs interfere significantly with the participant's usual function.
Time frame: Baseline through Day 60
Population: The safety population included all enrolled participants who received the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Number of Treatment-Emergent Hemophilia AEs by Severity | Mild Hemophilia AEs | 1 adverse events |
| PF-05280602 0.5 mcg/kg | Number of Treatment-Emergent Hemophilia AEs by Severity | Severe Hemophilia AEs | 0 adverse events |
| PF-05280602 0.5 mcg/kg | Number of Treatment-Emergent Hemophilia AEs by Severity | Moderate Hemophilia AEs | 1 adverse events |
| PF-05280602 4.5 mcg/kg | Number of Treatment-Emergent Hemophilia AEs by Severity | Moderate Hemophilia AEs | 1 adverse events |
| PF-05280602 4.5 mcg/kg | Number of Treatment-Emergent Hemophilia AEs by Severity | Mild Hemophilia AEs | 0 adverse events |
| PF-05280602 4.5 mcg/kg | Number of Treatment-Emergent Hemophilia AEs by Severity | Severe Hemophilia AEs | 0 adverse events |
| PF-05280602 9.0 mcg/kg | Number of Treatment-Emergent Hemophilia AEs by Severity | Moderate Hemophilia AEs | 2 adverse events |
| PF-05280602 9.0 mcg/kg | Number of Treatment-Emergent Hemophilia AEs by Severity | Mild Hemophilia AEs | 0 adverse events |
| PF-05280602 9.0 mcg/kg | Number of Treatment-Emergent Hemophilia AEs by Severity | Severe Hemophilia AEs | 0 adverse events |
| PF-05280602 18.0 mcg/kg | Number of Treatment-Emergent Hemophilia AEs by Severity | Mild Hemophilia AEs | 0 adverse events |
| PF-05280602 18.0 mcg/kg | Number of Treatment-Emergent Hemophilia AEs by Severity | Severe Hemophilia AEs | 0 adverse events |
| PF-05280602 18.0 mcg/kg | Number of Treatment-Emergent Hemophilia AEs by Severity | Moderate Hemophilia AEs | 1 adverse events |
| PF-05280602 30.0 mcg/kg | Number of Treatment-Emergent Hemophilia AEs by Severity | Moderate Hemophilia AEs | 2 adverse events |
| PF-05280602 30.0 mcg/kg | Number of Treatment-Emergent Hemophilia AEs by Severity | Mild Hemophilia AEs | 0 adverse events |
| PF-05280602 30.0 mcg/kg | Number of Treatment-Emergent Hemophilia AEs by Severity | Severe Hemophilia AEs | 0 adverse events |
Secondary
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
AUCinf is area under the plasma concentration-time curve from time 0 extrapolated to infinite time.
Time frame: Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)
Population: The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | NA ng*hr/mL | — |
| PF-05280602 4.5 mcg/kg | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | 300.7 ng*hr/mL | Geometric Coefficient of Variation 15 |
| PF-05280602 9.0 mcg/kg | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | 638.9 ng*hr/mL | Geometric Coefficient of Variation 21 |
| PF-05280602 18.0 mcg/kg | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | 1557 ng*hr/mL | Geometric Coefficient of Variation 19 |
| PF-05280602 30.0 mcg/kg | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | 2788 ng*hr/mL | Geometric Coefficient of Variation 31 |
Secondary
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time frame: Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)
Population: The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 3.82 ng*hr/mL | — |
| PF-05280602 4.5 mcg/kg | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 300.7 ng*hr/mL | Geometric Coefficient of Variation 15 |
| PF-05280602 9.0 mcg/kg | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 638.9 ng*hr/mL | Geometric Coefficient of Variation 21 |
| PF-05280602 18.0 mcg/kg | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 1557 ng*hr/mL | Geometric Coefficient of Variation 19 |
| PF-05280602 30.0 mcg/kg | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 2788 ng*hr/mL | Geometric Coefficient of Variation 31 |
Secondary
Clearance (CL)
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose is influenced by the fraction of the dose absorbed.
Time frame: Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)
Population: The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Clearance (CL) | NA L/hr/kg | — |
| PF-05280602 4.5 mcg/kg | Clearance (CL) | 0.01502 L/hr/kg | Geometric Coefficient of Variation 15 |
| PF-05280602 9.0 mcg/kg | Clearance (CL) | 0.01423 L/hr/kg | Geometric Coefficient of Variation 21 |
| PF-05280602 18.0 mcg/kg | Clearance (CL) | 0.01149 L/hr/kg | Geometric Coefficient of Variation 20 |
| PF-05280602 30.0 mcg/kg | Clearance (CL) | 0.01089 L/hr/kg | Geometric Coefficient of Variation 31 |
Secondary
Incremental Recovery (IncRec)
IncRec is the maximum rise in plasma concentration per administered dose.
Time frame: Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)
Population: The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Incremental Recovery (IncRec) | 3.48 ng/mL/mcg/kg | — |
| PF-05280602 4.5 mcg/kg | Incremental Recovery (IncRec) | 18.49 ng/mL/mcg/kg | Geometric Coefficient of Variation 20 |
| PF-05280602 9.0 mcg/kg | Incremental Recovery (IncRec) | 20.06 ng/mL/mcg/kg | Geometric Coefficient of Variation 28 |
| PF-05280602 18.0 mcg/kg | Incremental Recovery (IncRec) | 27.67 ng/mL/mcg/kg | Geometric Coefficient of Variation 16 |
| PF-05280602 30.0 mcg/kg | Incremental Recovery (IncRec) | 26.87 ng/mL/mcg/kg | Geometric Coefficient of Variation 24 |
Secondary
Maximum Mean Decrease From Baseline in Activated Partial Thromboplastin Time (aPTT)
aPTT is a blood test that characterizes blood coagulation. Maximum mean decrease from baseline at any time point was reported.
Time frame: Baseline through Day 15
Population: The safety population included all enrolled participants who received the study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Maximum Mean Decrease From Baseline in Activated Partial Thromboplastin Time (aPTT) | -1.30 seconds | — |
| PF-05280602 4.5 mcg/kg | Maximum Mean Decrease From Baseline in Activated Partial Thromboplastin Time (aPTT) | -17.93 seconds | Standard Deviation 8.944 |
| PF-05280602 9.0 mcg/kg | Maximum Mean Decrease From Baseline in Activated Partial Thromboplastin Time (aPTT) | -24.47 seconds | Standard Deviation 12.273 |
| PF-05280602 18.0 mcg/kg | Maximum Mean Decrease From Baseline in Activated Partial Thromboplastin Time (aPTT) | -43.02 seconds | Standard Deviation 16.541 |
| PF-05280602 30.0 mcg/kg | Maximum Mean Decrease From Baseline in Activated Partial Thromboplastin Time (aPTT) | -46.85 seconds | Standard Deviation 12.281 |
Secondary
Maximum Mean Decrease From Baseline in Prothrombin Time (PT)
PT measures how long it takes blood to clot. Maximum mean decrease from baseline at any time point was reported.
Time frame: Baseline through Day 15
Population: The safety population included all enrolled participants who received the study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Maximum Mean Decrease From Baseline in Prothrombin Time (PT) | -0.70 seconds | — |
| PF-05280602 4.5 mcg/kg | Maximum Mean Decrease From Baseline in Prothrombin Time (PT) | -3.37 seconds | Standard Deviation 0.372 |
| PF-05280602 9.0 mcg/kg | Maximum Mean Decrease From Baseline in Prothrombin Time (PT) | -3.80 seconds | Standard Deviation 0.629 |
| PF-05280602 18.0 mcg/kg | Maximum Mean Decrease From Baseline in Prothrombin Time (PT) | -3.85 seconds | Standard Deviation 0.409 |
| PF-05280602 30.0 mcg/kg | Maximum Mean Decrease From Baseline in Prothrombin Time (PT) | -4.45 seconds | Standard Deviation 0.493 |
Secondary
Maximum Mean Decrease From Baseline in Thrombin Generation Lag Time
The lag time is defined as the time to reach one sixth of the peak height and is a measure of the initiation phase. It is equivalent to the clotting time. Maximum mean decrease from baseline at any time point was reported.
Time frame: Baseline through Day 3
Population: The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Maximum Mean Decrease From Baseline in Thrombin Generation Lag Time | -0.540 minutes | — |
| PF-05280602 4.5 mcg/kg | Maximum Mean Decrease From Baseline in Thrombin Generation Lag Time | -6.235 minutes | Standard Deviation 5.7141 |
| PF-05280602 9.0 mcg/kg | Maximum Mean Decrease From Baseline in Thrombin Generation Lag Time | -7.088 minutes | Standard Deviation 7.9294 |
| PF-05280602 18.0 mcg/kg | Maximum Mean Decrease From Baseline in Thrombin Generation Lag Time | -13.400 minutes | Standard Deviation 14.6902 |
| PF-05280602 30.0 mcg/kg | Maximum Mean Decrease From Baseline in Thrombin Generation Lag Time | -2.425 minutes | Standard Deviation 0.9507 |
Secondary
Maximum Mean Increase From Baseline in D-Dimers
D-dimer is an indicator of fibrin formation and its subsequent lysis and is a useful biomarker representing overall activation of blood coagulation. Maximum mean increase from baseline at any time point was reported.
Time frame: Baseline through Day 15
Population: The safety population included all enrolled participants who received the study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Maximum Mean Increase From Baseline in D-Dimers | 240.0 ng/mL | — |
| PF-05280602 4.5 mcg/kg | Maximum Mean Increase From Baseline in D-Dimers | 75.0 ng/mL | Standard Deviation 103.68 |
| PF-05280602 9.0 mcg/kg | Maximum Mean Increase From Baseline in D-Dimers | 28.3 ng/mL | Standard Deviation 173.6 |
| PF-05280602 18.0 mcg/kg | Maximum Mean Increase From Baseline in D-Dimers | 88.3 ng/mL | Standard Deviation 123.36 |
| PF-05280602 30.0 mcg/kg | Maximum Mean Increase From Baseline in D-Dimers | 238.3 ng/mL | Standard Deviation 285.06 |
Secondary
Maximum Mean Increase From Baseline in Endogenous Thrombin Potential (ETP)
ETP was evaluated using a Thrombin Generation Assay (TGA), a validated automated ex-vivo assay that measures the ability of plasma to generate thrombin. Thrombin generation curves are generated and calculated using dedicated software. ETP is the area under the thrombin generation curve and represents the total amount of generated thrombin. Maximum mean increase from baseline at any time point was reported.
Time frame: Baseline through Day 3
Population: The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Maximum Mean Increase From Baseline in Endogenous Thrombin Potential (ETP) | 13.400 nanomolar*minute (nM*min) | — |
| PF-05280602 4.5 mcg/kg | Maximum Mean Increase From Baseline in Endogenous Thrombin Potential (ETP) | 212.643 nanomolar*minute (nM*min) | Standard Deviation 77.3337 |
| PF-05280602 9.0 mcg/kg | Maximum Mean Increase From Baseline in Endogenous Thrombin Potential (ETP) | 186.196 nanomolar*minute (nM*min) | Standard Deviation 147.6925 |
| PF-05280602 18.0 mcg/kg | Maximum Mean Increase From Baseline in Endogenous Thrombin Potential (ETP) | 287.173 nanomolar*minute (nM*min) | Standard Deviation 421.1883 |
| PF-05280602 30.0 mcg/kg | Maximum Mean Increase From Baseline in Endogenous Thrombin Potential (ETP) | 522.758 nanomolar*minute (nM*min) | Standard Deviation 94.0122 |
Secondary
Maximum Mean Increase From Baseline in Peak Thrombin Generation
The peak height is defined as the maximum thrombin concentration produced. Maximum mean increase from baseline at any time point was reported.
Time frame: Baseline through Day 3
Population: The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Maximum Mean Increase From Baseline in Peak Thrombin Generation | -0.620 Nanomolar (nM) | — |
| PF-05280602 4.5 mcg/kg | Maximum Mean Increase From Baseline in Peak Thrombin Generation | 17.982 Nanomolar (nM) | Standard Deviation 6.0924 |
| PF-05280602 9.0 mcg/kg | Maximum Mean Increase From Baseline in Peak Thrombin Generation | 16.568 Nanomolar (nM) | Standard Deviation 12.9124 |
| PF-05280602 18.0 mcg/kg | Maximum Mean Increase From Baseline in Peak Thrombin Generation | 23.362 Nanomolar (nM) | Standard Deviation 28.4618 |
| PF-05280602 30.0 mcg/kg | Maximum Mean Increase From Baseline in Peak Thrombin Generation | 49.130 Nanomolar (nM) | Standard Deviation 21.0371 |
Secondary
Maximum Mean Increase From Baseline in Prothrombin Fragments 1+2
Prothrombin fragment 1+2 is a coagulation factor, released when prothrombin is cleaved by activated Factor X. Elevated plasma levels of prothrombin fragment 1+2 indicate high risk of thrombosis. Maximum mean increase from baseline at any time point was reported.
Time frame: Baseline through Day 3
Population: The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Maximum Mean Increase From Baseline in Prothrombin Fragments 1+2 | 38.0 picomoles per liter (pmol/L) | — |
| PF-05280602 4.5 mcg/kg | Maximum Mean Increase From Baseline in Prothrombin Fragments 1+2 | 31.8 picomoles per liter (pmol/L) | Standard Deviation 30.56 |
| PF-05280602 9.0 mcg/kg | Maximum Mean Increase From Baseline in Prothrombin Fragments 1+2 | 66.4 picomoles per liter (pmol/L) | Standard Deviation 84.73 |
| PF-05280602 18.0 mcg/kg | Maximum Mean Increase From Baseline in Prothrombin Fragments 1+2 | 76.7 picomoles per liter (pmol/L) | Standard Deviation 28.27 |
| PF-05280602 30.0 mcg/kg | Maximum Mean Increase From Baseline in Prothrombin Fragments 1+2 | 238.3 picomoles per liter (pmol/L) | Standard Deviation 162.22 |
Secondary
Maximum Mean Increase From Baseline in Thrombin Anti-Thrombin (TAT) Complexes
TAT complex is a parameter of coagulation and fibrinolysis. The normal reference range of values for TAT is 1 to 4.1 mcg/L. Elevated TAT concentrations may signify predisposition to thrombosis. Maximum mean increase from baseline at any time point was reported.
Time frame: Baseline through Day 3
Population: The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Maximum Mean Increase From Baseline in Thrombin Anti-Thrombin (TAT) Complexes | 3.70 mcg/L | — |
| PF-05280602 4.5 mcg/kg | Maximum Mean Increase From Baseline in Thrombin Anti-Thrombin (TAT) Complexes | 23.82 mcg/L | Standard Deviation 51.13 |
| PF-05280602 9.0 mcg/kg | Maximum Mean Increase From Baseline in Thrombin Anti-Thrombin (TAT) Complexes | 4.72 mcg/L | Standard Deviation 5.282 |
| PF-05280602 18.0 mcg/kg | Maximum Mean Increase From Baseline in Thrombin Anti-Thrombin (TAT) Complexes | 5.52 mcg/L | Standard Deviation 6.53 |
| PF-05280602 30.0 mcg/kg | Maximum Mean Increase From Baseline in Thrombin Anti-Thrombin (TAT) Complexes | 22.47 mcg/L | Standard Deviation 28.01 |
Secondary
Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)
Population: The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Maximum Observed Plasma Concentration (Cmax) | 1.68 ng/mL | — |
| PF-05280602 4.5 mcg/kg | Maximum Observed Plasma Concentration (Cmax) | 84.78 ng/mL | Geometric Coefficient of Variation 20 |
| PF-05280602 9.0 mcg/kg | Maximum Observed Plasma Concentration (Cmax) | 183.1 ng/mL | Geometric Coefficient of Variation 28 |
| PF-05280602 18.0 mcg/kg | Maximum Observed Plasma Concentration (Cmax) | 496.2 ng/mL | Geometric Coefficient of Variation 14 |
| PF-05280602 30.0 mcg/kg | Maximum Observed Plasma Concentration (Cmax) | 814.8 ng/mL | Geometric Coefficient of Variation 23 |
Secondary
Mean Residence Time (MRT)
MRT is AUMCinf/AUCinf, where AUMC is the area under the first moment curve.
Time frame: Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)
Population: The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Mean Residence Time (MRT) | NA hours | — |
| PF-05280602 4.5 mcg/kg | Mean Residence Time (MRT) | 7.948 hours | Standard Deviation 1.786 |
| PF-05280602 9.0 mcg/kg | Mean Residence Time (MRT) | 5.697 hours | Standard Deviation 0.727 |
| PF-05280602 18.0 mcg/kg | Mean Residence Time (MRT) | 4.963 hours | Standard Deviation 0.741 |
| PF-05280602 30.0 mcg/kg | Mean Residence Time (MRT) | 5.087 hours | Standard Deviation 0.649 |
Secondary
Terminal Elimination Half-Life (t1/2)
t1/2 is the time measured for the plasma concentration to decrease by one half.
Time frame: Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)
Population: The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Terminal Elimination Half-Life (t1/2) | NA hour | — |
| PF-05280602 4.5 mcg/kg | Terminal Elimination Half-Life (t1/2) | 3.533 hour | Standard Deviation 0.56 |
| PF-05280602 9.0 mcg/kg | Terminal Elimination Half-Life (t1/2) | 3.637 hour | Standard Deviation 0.803 |
| PF-05280602 18.0 mcg/kg | Terminal Elimination Half-Life (t1/2) | 3.303 hour | Standard Deviation 0.638 |
| PF-05280602 30.0 mcg/kg | Terminal Elimination Half-Life (t1/2) | 3.580 hour | Standard Deviation 0.564 |
Secondary
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)
Population: The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0.167 hours | — |
| PF-05280602 4.5 mcg/kg | Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0.167 hours | Full Range 15 |
| PF-05280602 9.0 mcg/kg | Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0.242 hours | Full Range 21 |
| PF-05280602 18.0 mcg/kg | Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0.142 hours | Full Range 20 |
| PF-05280602 30.0 mcg/kg | Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0.150 hours | Full Range 31 |
Secondary
Volume of Distribution at Steady State (Vss)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Time frame: Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)
Population: The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-05280602 0.5 mcg/kg | Volume of Distribution at Steady State (Vss) | NA L/kg | — |
| PF-05280602 4.5 mcg/kg | Volume of Distribution at Steady State (Vss) | 0.1168 L/kg | Geometric Coefficient of Variation 35 |
| PF-05280602 9.0 mcg/kg | Volume of Distribution at Steady State (Vss) | 0.08060 L/kg | Geometric Coefficient of Variation 24 |
| PF-05280602 18.0 mcg/kg | Volume of Distribution at Steady State (Vss) | 0.05651 L/kg | Geometric Coefficient of Variation 21 |
| PF-05280602 30.0 mcg/kg | Volume of Distribution at Steady State (Vss) | 0.05494 L/kg | Geometric Coefficient of Variation 32 |