Intracerebral Hemorrhage
Conditions
Keywords
safety, maximum tolerated dose, modified continual reassessment method, intracerebral, hemorrhage, hematoma
Brief summary
This study employs a modified continual reassessment method (mCRM) design to estimate the maximum tolerated dose (MTD) of PF-05230907, defined as a target toxicity rate of 15% based on treatment emergent thromboembolic and/or ischemic events (TIEs). The mCRM design utilizes Bayesian methodology to continuously learn the dose-toxicity relationship, which is characterized by a parametric model. Subjects with a diagnosis of ICH (determined by computed tomography) will be enrolled in cohorts of 3. The total length of time planned for study participation is approximately 3 months; 6.0 hours for screening, a single dose administration with a 4-day minimum hospital confinement period and follow-up visits through Day 91. Severity of adverse events (AEs) and serious adverse events (SAEs) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. All subjects who receive PF-05230907 are evaluable for TIEs. The determination of MTD using mCRM modeling will be based on TIEs which occur through 7 days post-dose (Day 8).
Interventions
BIOLOGICALPF-05230907
PF-05230907 IV bolus injection
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* ICH as documented by CT scan within 6.0 hours of symptom onset * Baseline ICH volume \> 5mL and \< 60 mL
Exclusion criteria
* Deep coma (Glasgow Coma Scale \< 6) * Modified Rankin Score \> 3 prior to ICH onset * Known history of schemic, vaso-occlusive or thrombotic events within 6 months prior to screening * Known prothrombotic disorders * Known secondary ICH related to aneurysm, arteriovenous malformation, subarachnoid hemorrhage, trauma, or other causes. CT angiography, MR, or other diagnostic studies obtained as part of the standard of care may be used to assess eligibility. * Known use of oral anticoagulant(s) * Known use of low-molecular weight heparin or heparin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Changes From Baseline in Physical Examination | Baseline (pre-dose), Day 2, Day 3, Day 4, Day 8/discharge | Comprehensive and targeted physical examinations included general appearance, HEENT (head, eyes, ears, nose and throat), skin, heart (auscultation), lungs (auscultation), abdomen (palpitation and auscultation), and extremities with attention to swelling, general or localized tenderness, entire leg or calf swelling, edema, and collateral superficial veins. The results of the comprehensive and targeted physical examinations were combined to evaluate the changes from baseline through Day 8 (or discharge) for each site parameter according to the categories: positive change (abnormal to normal); no change (normal to normal or abnormal to abnormal); negative change (normal to abnormal). Parameters with at least 1 participant meeting the positive/negative change from baseline criteria are presented here. |
| Number of Participants With Treatment-Emergent Thromboembolic and/or Ischemic Events (TIEs) | Day 1 through day of discharge (Day 8) | Thromboembolic and/or ischemic events (TIEs) were defined as any of the following events: disseminated intravascular coagulation (Grade \[Gr\]\>=3); acute coronary syndrome (Gr \>=3); cardiac arrest (Gr \>=4); myocardial infarction (Gr \>=3); Cardiac troponin I increased (Gr 3); ischemia cerebrovascular (Gr \>=1 and associated with lesion\[s\]); portal vein thrombosis (Gr \>=2); ischemic stroke (Gr \>=1 and associated with lesion\[s\]); transient ischemic attacks (Gr 2); purpura (Gr \>=2); superior vena cava syndrome (Gr \>=1); thromboembolic event (Gr \>=2); visceral arterial ischemia (Gr \>=2); peripheral arterial ischemia (Gr \>=3). TIEs were graded based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For the respective event to count as a treatment-emergent TIE, onset or worsening of the event must have occurred following treatment with PF-05230907 and during the interval between Day 1 dosing through Day 8. |
| Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | Day 1 through follow-up visit (Day 43) | A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; or was life threatening (immediate risk of death); or required inpatient hospitalization or prolongation of existing hospitalization; or resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or resulted in congenital anomaly/birth defect. Any such events occurring following the start of treatment or increasing in severity were counted as treatment-emergent. |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) | Day 1 through day of discharge (Day 8) | An adverse event (AE) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. For the respective event to count as a treatment-emergent AE, onset or worsening of the event must have occurred following treatment with PF-05230907 and during the interval between Day 1 dosing through Day 8. |
| Number of Participants With Treatment-Emergent Laboratory Abnormalities | Day 1 through Day 8 (or discharge) for D-dimer laboratory test and urinalysis; Day 1 through Day 4 for all other laboratory tests | Laboratory safety parameters included hematology, blood chemistry, prothrombin time/international normalized ratio (PT/INR), fibrinogen, antithrombin III (ATIII), Protein S level, Protein C activity, cardiac troponin I, D-dimer, and urinalysis. The number of participants with laboratory test abnormalities meeting specified criteria without regard to baseline abnormality was assessed. Any abnormalities occurring after the administration of treatment and increasing in severity from baseline value were counted as treatment-emergent. |
| Change From Baseline for Body Temperature | Baseline (pre-dose), Day 1 (5 and 45 minutes [min] post-dose), Day 2, Day 3, Day 4, Day 8/discharge | Body temperature was measured by oral, tympanic, axillary or temporal method. |
| Number of Participants With Electrocardiogram (ECG) Qualitative Results | Baseline (pre-dose), Day 2, Day 4, Day 8/discharge | The electrocardiogram (ECG) results over time were compared to baseline and assessed by the investigator as less abnormal, no significant change, or more abnormal. |
| Change From Baseline for Supine Pulse Rate | Baseline (pre-dose), Day 1 (5 and 45 minutes [min] post-dose), Day 2, Day 3, Day 4, Day 8/discharge | The use of an automated device for measuring pulse rate was acceptable, although, when done manually, pulse rate was measured in the brachial/radial artery for at least 30 seconds. |
| Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Baseline (pre-dose), Day 1 (5 and 45 minutes [min] post-dose), Day 2, Day 3, Day 4, Day 8/discharge | Supine blood pressure (BP, systolic and diastolic) was measured with the participant's arm supported at the level of the heart and recorded to the nearest milliliters of mercury (mmHg) after 5 minutes of rest whenever possible and as permitted by the participant's medical condition. |
| Change From Baseline for Supine Respiratory Rate | Baseline (pre-dose), Day 1 (5 and 45 minutes [min] post-dose), Day 2, Day 3, Day 4, Day 8/discharge | Respiratory rate was measured after 5 minutes rest in supine position by observing and counting the respirations of the participant for 30 seconds and multiplied by 2. The use of an automated device for measuring respiratory rate was acceptable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Depletion of Coagulation Factor X | Baseline (pre-dose), Day 43, Day 91 | Depletion of coagulation factor X was defined as \>50% reduction relative to baseline (pre-dose). |
| Maximum Changes From Baseline for Activated Partial Thromboplastin Time (aPTT) | Baseline (pre-dose), Day 2 | Maximum changes from baseline were calculated for activated partial thromboplastin time (aPTT) after dosing with PF-05230907 through Day 2. |
| Maximum Changes From Baseline for Prothrombin Fragment 1+2 (PF1+2) | Baseline (pre-dose), Day 2 | Maximum changes from baseline were calculated for prothrombin fragment 1+2 (PF1+2) after dosing with PF-05230907 through Day 2. |
| Number of Participants With Anti-Drug Antibody (ADA) Production | Day 1 up to follow-up visit (Day 43 and/or Day 91) | Participants with anti-drug antibody (ADA) production were those with at least 1 positive result from Day 1 through follow-up visit (Day 43 and/or Day 91). ADA positive: titer value \>=1.88. |
| Number of Participants With Neutralizing Antibody (NAb) Production | Day 1 up to follow-up visit (Day 43 and/or Day 91) | ADA positive samples were planned to be further characterized for neutralizing antibody (NAb). Participants with NAb production were those with at least 1 positive result from Day 1 through follow-up visit (Day 43 and/or Day 91). As all ADA samples were negative (titer value \<1.88), NAb analysis was not conducted. |
Other
| Measure | Time frame | Description |
|---|---|---|
| PF-05230907 Concentration in Plasma | Day 1 pre-dose, 5 and 45 minutes post-dose | — |
| Health Resource Utilization Surrogate Measures - Maximum Duration | Day 1 up to Day 91 | Maximum duration for 4 types of hospital or health care unit: Intensive Care Unit (ICU), general ward, rehabilitation center, and other hospital units. This was an exploratory endpoint to evaluate information for designing future studies, which were no longer planned. |
| Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Screening, Day 1, Day 2, Day 4, Day 43, and Day 91 | The National Institute of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The total NIHSS score range is from 0 (normal) to 42 (severe impairment), with higher values indicating greater level of neurological impairment. |
| Number of Participants With Anti-Paired Basic Amino Acid Cleaving Enzyme (PACE) Furin Antibody Production | Day 1, Day 43 | Participants with anti-paired basic amino acid cleaving enzyme (PACE) antibody production were those with positive results. Positive: titer value \>=2.00. |
| Number of Participants With Anti-Chinese Hamster Ovary (CHO) Protein Antibody Production | Day 1, Day 43 | Participants with anti-Chinese hamster ovary (CHO) antibody production were those with positive results. Positive: titer value \>=2.00. |
| Change From Baseline in Intracerebral Hemorrhage (ICH) Volume at 24 Hours | Baseline (pre-dose), 24 hours | Change from baseline in intracerebral hemorrhage (ICH) volume was calculated at 24 hours. |
Countries
Canada, Spain, United Kingdom, United States
Participant flow
Pre-assignment details
Not all the 15 pre-specified dose groups (possible doses based on Bayesian modified continual reassessment method \[mCRM\]) were expected to be studied. The actual doses were determined by mCRM and safety review. Study results were reported for the 6 actual dose groups allocated with participants.
Participants by arm
| Arm | Count |
|---|---|
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1. | 3 |
| PF-05230907 8 mcg/kg PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1. | 3 |
| PF-05230907 12 mcg/kg PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1. | 3 |
| PF-05230907 19 mcg/kg PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1. | 6 |
| PF-05230907 24 mcg/kg PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1. | 3 |
| PF-05230907 30 mcg/kg PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1. | 3 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 1 | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | PF-05230907 5 Microgram Per Kilogram (mcg/kg) | PF-05230907 8 mcg/kg | PF-05230907 12 mcg/kg | PF-05230907 19 mcg/kg | PF-05230907 24 mcg/kg | PF-05230907 30 mcg/kg | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 49.7 years STANDARD_DEVIATION 5.5 | 65.7 years STANDARD_DEVIATION 5.5 | 62.3 years STANDARD_DEVIATION 11.9 | 62.2 years STANDARD_DEVIATION 8.1 | 66.7 years STANDARD_DEVIATION 3.8 | 67.7 years STANDARD_DEVIATION 9.6 | 62.3 years STANDARD_DEVIATION 9 |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 2 Participants | 3 Participants | 3 Participants | 4 Participants | 3 Participants | 3 Participants | 18 Participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 2 Participants | 7 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 1 Participants | 5 Participants | 3 Participants | 1 Participants | 14 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 | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 1 / 3 | 1 / 3 | 0 / 6 | 2 / 3 | 1 / 3 |
| other Total, other adverse events | 2 / 3 | 3 / 3 | 3 / 3 | 5 / 6 | 3 / 3 | 3 / 3 |
| serious Total, serious adverse events | 0 / 3 | 1 / 3 | 1 / 3 | 0 / 6 | 2 / 3 | 2 / 3 |
Outcome results
Primary
Change From Baseline for Body Temperature
Body temperature was measured by oral, tympanic, axillary or temporal method.
Time frame: Baseline (pre-dose), Day 1 (5 and 45 minutes [min] post-dose), Day 2, Day 3, Day 4, Day 8/discharge
Population: All participants who received the treatment of PF-05230907. Number Analyzed represents the number of participants evaluable for each specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Body Temperature | Day 1 (5 min) | 0.1 Degree Celsius (°C) | Standard Deviation 0.1 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Body Temperature | Day 1 (45 min) | 0.1 Degree Celsius (°C) | Standard Deviation 0.1 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Body Temperature | Day 2 | 0.4 Degree Celsius (°C) | Standard Deviation 0.76 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Body Temperature | Day 3 | 0.6 Degree Celsius (°C) | Standard Deviation 0.72 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Body Temperature | Day 4 | 0.1 Degree Celsius (°C) | Standard Deviation 0.26 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Body Temperature | Day 8/discharge | -0.2 Degree Celsius (°C) | Standard Deviation 0.35 |
| PF-05230907 8 mcg/kg | Change From Baseline for Body Temperature | Day 1 (45 min) | -0.2 Degree Celsius (°C) | Standard Deviation 0.26 |
| PF-05230907 8 mcg/kg | Change From Baseline for Body Temperature | Day 3 | 0.5 Degree Celsius (°C) | Standard Deviation 0.2 |
| PF-05230907 8 mcg/kg | Change From Baseline for Body Temperature | Day 8/discharge | 0.1 Degree Celsius (°C) | Standard Deviation 0.28 |
| PF-05230907 8 mcg/kg | Change From Baseline for Body Temperature | Day 1 (5 min) | -0.2 Degree Celsius (°C) | Standard Deviation 0.21 |
| PF-05230907 8 mcg/kg | Change From Baseline for Body Temperature | Day 2 | 0.5 Degree Celsius (°C) | Standard Deviation 0.35 |
| PF-05230907 8 mcg/kg | Change From Baseline for Body Temperature | Day 4 | 0.0 Degree Celsius (°C) | Standard Deviation 0.06 |
| PF-05230907 12 mcg/kg | Change From Baseline for Body Temperature | Day 8/discharge | 0.5 Degree Celsius (°C) | Standard Deviation 0.7 |
| PF-05230907 12 mcg/kg | Change From Baseline for Body Temperature | Day 4 | 1.1 Degree Celsius (°C) | Standard Deviation 0.99 |
| PF-05230907 12 mcg/kg | Change From Baseline for Body Temperature | Day 3 | 1.1 Degree Celsius (°C) | Standard Deviation 0.45 |
| PF-05230907 12 mcg/kg | Change From Baseline for Body Temperature | Day 2 | 0.2 Degree Celsius (°C) | Standard Deviation 1.36 |
| PF-05230907 12 mcg/kg | Change From Baseline for Body Temperature | Day 1 (5 min) | 0.4 Degree Celsius (°C) | Standard Deviation 0.57 |
| PF-05230907 12 mcg/kg | Change From Baseline for Body Temperature | Day 1 (45 min) | 0.4 Degree Celsius (°C) | Standard Deviation 0.57 |
| PF-05230907 19 mcg/kg | Change From Baseline for Body Temperature | Day 3 | 1.1 Degree Celsius (°C) | Standard Deviation 1.06 |
| PF-05230907 19 mcg/kg | Change From Baseline for Body Temperature | Day 1 (45 min) | -0.1 Degree Celsius (°C) | Standard Deviation 0.28 |
| PF-05230907 19 mcg/kg | Change From Baseline for Body Temperature | Day 2 | 0.5 Degree Celsius (°C) | Standard Deviation 0.98 |
| PF-05230907 19 mcg/kg | Change From Baseline for Body Temperature | Day 8/discharge | 0.4 Degree Celsius (°C) | Standard Deviation 0.78 |
| PF-05230907 19 mcg/kg | Change From Baseline for Body Temperature | Day 4 | 0.4 Degree Celsius (°C) | Standard Deviation 0.85 |
| PF-05230907 19 mcg/kg | Change From Baseline for Body Temperature | Day 1 (5 min) | -0.1 Degree Celsius (°C) | Standard Deviation 0.52 |
| PF-05230907 24 mcg/kg | Change From Baseline for Body Temperature | Day 1 (5 min) | 0.4 Degree Celsius (°C) | Standard Deviation 0.55 |
| PF-05230907 24 mcg/kg | Change From Baseline for Body Temperature | Day 4 | 0.7 Degree Celsius (°C) | Standard Deviation 1.43 |
| PF-05230907 24 mcg/kg | Change From Baseline for Body Temperature | Day 1 (45 min) | 0.4 Degree Celsius (°C) | Standard Deviation 0.61 |
| PF-05230907 24 mcg/kg | Change From Baseline for Body Temperature | Day 2 | 1.0 Degree Celsius (°C) | Standard Deviation 1.1 |
| PF-05230907 24 mcg/kg | Change From Baseline for Body Temperature | Day 3 | 0.9 Degree Celsius (°C) | Standard Deviation 1.63 |
| PF-05230907 24 mcg/kg | Change From Baseline for Body Temperature | Day 8/discharge | -0.1 Degree Celsius (°C) | Standard Deviation 0.28 |
| PF-05230907 30 mcg/kg | Change From Baseline for Body Temperature | Day 3 | 0.1 Degree Celsius (°C) | Standard Deviation 0.65 |
| PF-05230907 30 mcg/kg | Change From Baseline for Body Temperature | Day 2 | 0.0 Degree Celsius (°C) | Standard Deviation 0.35 |
| PF-05230907 30 mcg/kg | Change From Baseline for Body Temperature | Day 4 | 0.1 Degree Celsius (°C) | Standard Deviation 0.25 |
| PF-05230907 30 mcg/kg | Change From Baseline for Body Temperature | Day 8/discharge | -0.4 Degree Celsius (°C) | Standard Deviation 0.68 |
| PF-05230907 30 mcg/kg | Change From Baseline for Body Temperature | Day 1 (45 min) | 0.0 Degree Celsius (°C) | Standard Deviation 0.3 |
| PF-05230907 30 mcg/kg | Change From Baseline for Body Temperature | Day 1 (5 min) | 0.1 Degree Celsius (°C) | Standard Deviation 0.1 |
Primary
Change From Baseline for Supine Pulse Rate
The use of an automated device for measuring pulse rate was acceptable, although, when done manually, pulse rate was measured in the brachial/radial artery for at least 30 seconds.
Time frame: Baseline (pre-dose), Day 1 (5 and 45 minutes [min] post-dose), Day 2, Day 3, Day 4, Day 8/discharge
Population: All participants who received the treatment of PF-05230907. Number Analyzed represents the number of participants evaluable for each specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Supine Pulse Rate | Day 1 (5 min) | -0.7 beats per minute (bpm) | Standard Deviation 5.69 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Supine Pulse Rate | Day 1 (45 min) | 8.0 beats per minute (bpm) | Standard Deviation 20.07 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Supine Pulse Rate | Day 2 | -13.0 beats per minute (bpm) | Standard Deviation 19.97 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Supine Pulse Rate | Day 3 | -12.3 beats per minute (bpm) | Standard Deviation 22.28 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Supine Pulse Rate | Day 4 | -13.7 beats per minute (bpm) | Standard Deviation 31.53 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Supine Pulse Rate | Day 8/discharge | -16.5 beats per minute (bpm) | Standard Deviation 36.06 |
| PF-05230907 8 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 1 (45 min) | -1.3 beats per minute (bpm) | Standard Deviation 23.18 |
| PF-05230907 8 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 3 | -13.0 beats per minute (bpm) | Standard Deviation 7.94 |
| PF-05230907 8 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 8/discharge | -18.0 beats per minute (bpm) | Standard Deviation 7.07 |
| PF-05230907 8 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 1 (5 min) | 1.3 beats per minute (bpm) | Standard Deviation 4.16 |
| PF-05230907 8 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 2 | -21.0 beats per minute (bpm) | Standard Deviation 18.73 |
| PF-05230907 8 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 4 | -21.0 beats per minute (bpm) | Standard Deviation 12.12 |
| PF-05230907 12 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 8/discharge | -1.7 beats per minute (bpm) | Standard Deviation 4.16 |
| PF-05230907 12 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 4 | -11.0 beats per minute (bpm) | Standard Deviation 9.85 |
| PF-05230907 12 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 3 | 1.0 beats per minute (bpm) | Standard Deviation 12 |
| PF-05230907 12 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 2 | 5.7 beats per minute (bpm) | Standard Deviation 1.15 |
| PF-05230907 12 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 1 (5 min) | 1.7 beats per minute (bpm) | Standard Deviation 1.53 |
| PF-05230907 12 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 1 (45 min) | -2.7 beats per minute (bpm) | Standard Deviation 7.51 |
| PF-05230907 19 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 3 | 9.2 beats per minute (bpm) | Standard Deviation 13.53 |
| PF-05230907 19 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 1 (45 min) | -0.2 beats per minute (bpm) | Standard Deviation 5.98 |
| PF-05230907 19 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 2 | -2.7 beats per minute (bpm) | Standard Deviation 5.89 |
| PF-05230907 19 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 8/discharge | 6.2 beats per minute (bpm) | Standard Deviation 8.04 |
| PF-05230907 19 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 4 | -3.7 beats per minute (bpm) | Standard Deviation 10.84 |
| PF-05230907 19 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 1 (5 min) | 0.0 beats per minute (bpm) | Standard Deviation 2.45 |
| PF-05230907 24 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 1 (5 min) | -17.3 beats per minute (bpm) | Standard Deviation 17.01 |
| PF-05230907 24 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 4 | -12.7 beats per minute (bpm) | Standard Deviation 30.17 |
| PF-05230907 24 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 1 (45 min) | -13.3 beats per minute (bpm) | Standard Deviation 10.07 |
| PF-05230907 24 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 2 | -11.0 beats per minute (bpm) | Standard Deviation 16.37 |
| PF-05230907 24 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 3 | -14.3 beats per minute (bpm) | Standard Deviation 17.21 |
| PF-05230907 24 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 8/discharge | -34.0 beats per minute (bpm) | Standard Deviation 0 |
| PF-05230907 30 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 3 | 3.0 beats per minute (bpm) | Standard Deviation 25.94 |
| PF-05230907 30 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 2 | -3.3 beats per minute (bpm) | Standard Deviation 21.5 |
| PF-05230907 30 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 4 | 7.3 beats per minute (bpm) | Standard Deviation 18.77 |
| PF-05230907 30 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 8/discharge | 2.0 beats per minute (bpm) | Standard Deviation 5.57 |
| PF-05230907 30 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 1 (45 min) | 2.7 beats per minute (bpm) | Standard Deviation 14.19 |
| PF-05230907 30 mcg/kg | Change From Baseline for Supine Pulse Rate | Day 1 (5 min) | 2.7 beats per minute (bpm) | Standard Deviation 4.62 |
Primary
Change From Baseline for Supine Respiratory Rate
Respiratory rate was measured after 5 minutes rest in supine position by observing and counting the respirations of the participant for 30 seconds and multiplied by 2. The use of an automated device for measuring respiratory rate was acceptable.
Time frame: Baseline (pre-dose), Day 1 (5 and 45 minutes [min] post-dose), Day 2, Day 3, Day 4, Day 8/discharge
Population: All participants who received the treatment of PF-05230907. Number Analyzed represents the number of participants evaluable for each specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Supine Respiratory Rate | Day 1 (5 min) | 0.0 respiration per minute | Standard Deviation 4 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Supine Respiratory Rate | Day 1 (45 min) | -2.3 respiration per minute | Standard Deviation 2.08 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Supine Respiratory Rate | Day 2 | -1.7 respiration per minute | Standard Deviation 0.58 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Supine Respiratory Rate | Day 3 | -1.0 respiration per minute | Standard Deviation 3 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Supine Respiratory Rate | Day 4 | 0.3 respiration per minute | Standard Deviation 2.52 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Supine Respiratory Rate | Day 8/discharge | -2.5 respiration per minute | Standard Deviation 0.71 |
| PF-05230907 8 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 1 (45 min) | 5.7 respiration per minute | Standard Deviation 1.53 |
| PF-05230907 8 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 3 | 5.3 respiration per minute | Standard Deviation 2.89 |
| PF-05230907 8 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 8/discharge | 2.5 respiration per minute | Standard Deviation 0.71 |
| PF-05230907 8 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 1 (5 min) | 3.7 respiration per minute | Standard Deviation 3.51 |
| PF-05230907 8 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 2 | 5.0 respiration per minute | Standard Deviation 3.61 |
| PF-05230907 8 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 4 | 4.0 respiration per minute | Standard Deviation 3.46 |
| PF-05230907 12 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 8/discharge | -2.0 respiration per minute | Standard Deviation 2.65 |
| PF-05230907 12 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 4 | -0.7 respiration per minute | Standard Deviation 3.79 |
| PF-05230907 12 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 3 | -1.0 respiration per minute | Standard Deviation 2.65 |
| PF-05230907 12 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 2 | -3.0 respiration per minute | Standard Deviation 1 |
| PF-05230907 12 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 1 (5 min) | -1.3 respiration per minute | Standard Deviation 2.52 |
| PF-05230907 12 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 1 (45 min) | -0.7 respiration per minute | Standard Deviation 2.52 |
| PF-05230907 19 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 3 | 0.0 respiration per minute | Standard Deviation 4.15 |
| PF-05230907 19 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 1 (45 min) | -1.2 respiration per minute | Standard Deviation 2.93 |
| PF-05230907 19 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 2 | -0.8 respiration per minute | Standard Deviation 2.86 |
| PF-05230907 19 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 8/discharge | 1.2 respiration per minute | Standard Deviation 2.71 |
| PF-05230907 19 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 4 | -1.0 respiration per minute | Standard Deviation 2.19 |
| PF-05230907 19 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 1 (5 min) | -1.5 respiration per minute | Standard Deviation 3 |
| PF-05230907 24 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 1 (5 min) | -0.3 respiration per minute | Standard Deviation 0.58 |
| PF-05230907 24 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 4 | 1.3 respiration per minute | Standard Deviation 4.16 |
| PF-05230907 24 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 1 (45 min) | 4.0 respiration per minute | Standard Deviation 6.93 |
| PF-05230907 24 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 2 | 0.0 respiration per minute | Standard Deviation 2 |
| PF-05230907 24 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 3 | 1.7 respiration per minute | Standard Deviation 2.89 |
| PF-05230907 24 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 8/discharge | -1.0 respiration per minute | Standard Deviation 1.41 |
| PF-05230907 30 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 3 | 0.3 respiration per minute | Standard Deviation 2.52 |
| PF-05230907 30 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 2 | -0.7 respiration per minute | Standard Deviation 0.58 |
| PF-05230907 30 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 4 | -0.7 respiration per minute | Standard Deviation 1.15 |
| PF-05230907 30 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 8/discharge | -2.7 respiration per minute | Standard Deviation 2.89 |
| PF-05230907 30 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 1 (45 min) | 0.0 respiration per minute | Standard Deviation 1 |
| PF-05230907 30 mcg/kg | Change From Baseline for Supine Respiratory Rate | Day 1 (5 min) | 0.7 respiration per minute | Standard Deviation 3.06 |
Primary
Change From Baseline for Supine Systolic and Diastolic Blood Pressure
Supine blood pressure (BP, systolic and diastolic) was measured with the participant's arm supported at the level of the heart and recorded to the nearest milliliters of mercury (mmHg) after 5 minutes of rest whenever possible and as permitted by the participant's medical condition.
Time frame: Baseline (pre-dose), Day 1 (5 and 45 minutes [min] post-dose), Day 2, Day 3, Day 4, Day 8/discharge
Population: All participants who received the treatment of PF-05230907. Number Analyzed represents the number of participants evaluable for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 2 | -0.7 milliliters of mercury (mmHg) | Standard Deviation 12.06 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 1 (5 min) | -6.3 milliliters of mercury (mmHg) | Standard Deviation 13.28 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 1 (45 min) | -11.3 milliliters of mercury (mmHg) | Standard Deviation 17.62 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 8/discharge | -12.0 milliliters of mercury (mmHg) | Standard Deviation 2.83 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 2 | -3.3 milliliters of mercury (mmHg) | Standard Deviation 8.14 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 4 | -14.0 milliliters of mercury (mmHg) | Standard Deviation 10.58 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 3 | -14.3 milliliters of mercury (mmHg) | Standard Deviation 19.09 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 4 | -12.0 milliliters of mercury (mmHg) | Standard Deviation 17.09 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 3 | -7.0 milliliters of mercury (mmHg) | Standard Deviation 6.24 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 8/discharge | -18.0 milliliters of mercury (mmHg) | Standard Deviation 5.66 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 1 (45 min) | -13.3 milliliters of mercury (mmHg) | Standard Deviation 12.01 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 1 (5 min) | -9.0 milliliters of mercury (mmHg) | Standard Deviation 15.59 |
| PF-05230907 8 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 8/discharge | -1.0 milliliters of mercury (mmHg) | Standard Deviation 26.87 |
| PF-05230907 8 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 1 (5 min) | 10.7 milliliters of mercury (mmHg) | Standard Deviation 11.02 |
| PF-05230907 8 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 2 | -8.0 milliliters of mercury (mmHg) | Standard Deviation 4 |
| PF-05230907 8 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 1 (45 min) | 15.0 milliliters of mercury (mmHg) | Standard Deviation 36.76 |
| PF-05230907 8 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 4 | 6.3 milliliters of mercury (mmHg) | Standard Deviation 30.37 |
| PF-05230907 8 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 3 | 5.3 milliliters of mercury (mmHg) | Standard Deviation 17.93 |
| PF-05230907 8 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 1 (5 min) | 27.7 milliliters of mercury (mmHg) | Standard Deviation 27.65 |
| PF-05230907 8 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 1 (45 min) | 7.3 milliliters of mercury (mmHg) | Standard Deviation 21.83 |
| PF-05230907 8 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 4 | -8.3 milliliters of mercury (mmHg) | Standard Deviation 16.17 |
| PF-05230907 8 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 2 | -7.3 milliliters of mercury (mmHg) | Standard Deviation 17.01 |
| PF-05230907 8 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 8/discharge | -4.0 milliliters of mercury (mmHg) | Standard Deviation 11.31 |
| PF-05230907 8 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 3 | -4.3 milliliters of mercury (mmHg) | Standard Deviation 11.93 |
| PF-05230907 12 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 4 | 8.7 milliliters of mercury (mmHg) | Standard Deviation 17.67 |
| PF-05230907 12 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 2 | -11.0 milliliters of mercury (mmHg) | Standard Deviation 11.53 |
| PF-05230907 12 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 2 | -4.7 milliliters of mercury (mmHg) | Standard Deviation 21.73 |
| PF-05230907 12 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 3 | 12.0 milliliters of mercury (mmHg) | Standard Deviation 7.21 |
| PF-05230907 12 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 8/discharge | 12.0 milliliters of mercury (mmHg) | Standard Deviation 19.67 |
| PF-05230907 12 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 3 | 5.0 milliliters of mercury (mmHg) | Standard Deviation 8.66 |
| PF-05230907 12 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 1 (5 min) | -7.3 milliliters of mercury (mmHg) | Standard Deviation 15.53 |
| PF-05230907 12 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 1 (45 min) | 9.3 milliliters of mercury (mmHg) | Standard Deviation 1.15 |
| PF-05230907 12 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 4 | -6.0 milliliters of mercury (mmHg) | Standard Deviation 12.49 |
| PF-05230907 12 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 1 (45 min) | -5.3 milliliters of mercury (mmHg) | Standard Deviation 38.28 |
| PF-05230907 12 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 1 (5 min) | -4.3 milliliters of mercury (mmHg) | Standard Deviation 8.14 |
| PF-05230907 12 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 8/discharge | -5.0 milliliters of mercury (mmHg) | Standard Deviation 18.03 |
| PF-05230907 19 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 1 (45 min) | -27.0 milliliters of mercury (mmHg) | Standard Deviation 25.11 |
| PF-05230907 19 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 1 (5 min) | -10.2 milliliters of mercury (mmHg) | Standard Deviation 12.56 |
| PF-05230907 19 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 1 (45 min) | -26.7 milliliters of mercury (mmHg) | Standard Deviation 27.53 |
| PF-05230907 19 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 2 | -29.8 milliliters of mercury (mmHg) | Standard Deviation 25.63 |
| PF-05230907 19 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 3 | -36.2 milliliters of mercury (mmHg) | Standard Deviation 26.16 |
| PF-05230907 19 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 4 | -32.5 milliliters of mercury (mmHg) | Standard Deviation 25.84 |
| PF-05230907 19 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 8/discharge | -22.8 milliliters of mercury (mmHg) | Standard Deviation 50.01 |
| PF-05230907 19 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 1 (5 min) | -21.6 milliliters of mercury (mmHg) | Standard Deviation 20.94 |
| PF-05230907 19 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 2 | -26.2 milliliters of mercury (mmHg) | Standard Deviation 32.39 |
| PF-05230907 19 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 3 | -28.2 milliliters of mercury (mmHg) | Standard Deviation 24.81 |
| PF-05230907 19 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 4 | -26.5 milliliters of mercury (mmHg) | Standard Deviation 21.77 |
| PF-05230907 19 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 8/discharge | -24.2 milliliters of mercury (mmHg) | Standard Deviation 36.31 |
| PF-05230907 24 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 4 | 7.3 milliliters of mercury (mmHg) | Standard Deviation 11.93 |
| PF-05230907 24 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 2 | -14.0 milliliters of mercury (mmHg) | Standard Deviation 8.54 |
| PF-05230907 24 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 1 (5 min) | 11.0 milliliters of mercury (mmHg) | Standard Deviation 12.12 |
| PF-05230907 24 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 8/discharge | 2.5 milliliters of mercury (mmHg) | Standard Deviation 7.78 |
| PF-05230907 24 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 4 | -5.7 milliliters of mercury (mmHg) | Standard Deviation 12.06 |
| PF-05230907 24 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 3 | 5.3 milliliters of mercury (mmHg) | Standard Deviation 34.56 |
| PF-05230907 24 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 1 (45 min) | 12.0 milliliters of mercury (mmHg) | Standard Deviation 20.95 |
| PF-05230907 24 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 2 | -7.3 milliliters of mercury (mmHg) | Standard Deviation 1.53 |
| PF-05230907 24 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 3 | 4.0 milliliters of mercury (mmHg) | Standard Deviation 12.17 |
| PF-05230907 24 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 1 (5 min) | 5.3 milliliters of mercury (mmHg) | Standard Deviation 9.24 |
| PF-05230907 24 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 1 (45 min) | 1.7 milliliters of mercury (mmHg) | Standard Deviation 7.64 |
| PF-05230907 24 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 8/discharge | 18.5 milliliters of mercury (mmHg) | Standard Deviation 3.54 |
| PF-05230907 30 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 1 (45 min) | 2.0 milliliters of mercury (mmHg) | Standard Deviation 2.65 |
| PF-05230907 30 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 4 | -27.7 milliliters of mercury (mmHg) | Standard Deviation 17.21 |
| PF-05230907 30 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 2 | -5.7 milliliters of mercury (mmHg) | Standard Deviation 8.74 |
| PF-05230907 30 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 3 | -15.7 milliliters of mercury (mmHg) | Standard Deviation 3.79 |
| PF-05230907 30 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 8/discharge | -6.0 milliliters of mercury (mmHg) | Standard Deviation 6.24 |
| PF-05230907 30 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 3 | -6.7 milliliters of mercury (mmHg) | Standard Deviation 4.16 |
| PF-05230907 30 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 2 | 0.7 milliliters of mercury (mmHg) | Standard Deviation 18.58 |
| PF-05230907 30 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 1 (45 min) | -6.7 milliliters of mercury (mmHg) | Standard Deviation 29.54 |
| PF-05230907 30 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 4 | -11.0 milliliters of mercury (mmHg) | Standard Deviation 19.97 |
| PF-05230907 30 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 1 (5 min) | 9.7 milliliters of mercury (mmHg) | Standard Deviation 7.23 |
| PF-05230907 30 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Diastolic BP, Day 1 (5 min) | 6.3 milliliters of mercury (mmHg) | Standard Deviation 2.08 |
| PF-05230907 30 mcg/kg | Change From Baseline for Supine Systolic and Diastolic Blood Pressure | Supine Systolic BP, Day 8/discharge | -14.3 milliliters of mercury (mmHg) | Standard Deviation 6.35 |
Primary
Number of Participants With Changes From Baseline in Physical Examination
Comprehensive and targeted physical examinations included general appearance, HEENT (head, eyes, ears, nose and throat), skin, heart (auscultation), lungs (auscultation), abdomen (palpitation and auscultation), and extremities with attention to swelling, general or localized tenderness, entire leg or calf swelling, edema, and collateral superficial veins. The results of the comprehensive and targeted physical examinations were combined to evaluate the changes from baseline through Day 8 (or discharge) for each site parameter according to the categories: positive change (abnormal to normal); no change (normal to normal or abnormal to abnormal); negative change (normal to abnormal). Parameters with at least 1 participant meeting the positive/negative change from baseline criteria are presented here.
Time frame: Baseline (pre-dose), Day 2, Day 3, Day 4, Day 8/discharge
Population: All participants who received the treatment of PF-05230907.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Eyes: Positive change, Day 2 | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Negative change, Day 3 | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Negative change, Day 4 | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Positive change, Day 3 | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Positive change, Day 4 | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Positive change, Day 8/discharge | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Eyes: Negative change, Day 3 | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Eyes: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Eyes: Positive change, Day 8/discharge | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Head: Negative change, Day 2 | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Head: Negative change, Day 4 | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Head: Positive change, Day 8/discharge | 1 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Heart: Negative change, Day 2 | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Heart: Negative change, Day 3 | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Heart: Negative change, Day 4 | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Heart: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Negative change, Day 2 | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Negative change, Day 4 | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Positive change, Day 2 | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Positive change, Day 8/discharge | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Neurological: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Abdomen: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Negative change, Day 2 | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Neurological: Positive change, Day 2 | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Neurological: Positive change, Day 3 | 1 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Neurological: Positive change, Day 4 | 1 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Skin: Positive change, Day 2 | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Skin: Positive change, Day 4 | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Skin: Positive change, Day 8/discharge | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Changes From Baseline in Physical Examination | Throat: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Neurological: Positive change, Day 3 | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Positive change, Day 4 | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Neurological: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Neurological: Positive change, Day 2 | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Skin: Positive change, Day 2 | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Abdomen: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Eyes: Positive change, Day 8/discharge | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Negative change, Day 3 | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Negative change, Day 2 | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Head: Negative change, Day 2 | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Head: Negative change, Day 4 | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Positive change, Day 8/discharge | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Head: Positive change, Day 8/discharge | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Positive change, Day 3 | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Neurological: Positive change, Day 4 | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Heart: Negative change, Day 2 | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Eyes: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Heart: Negative change, Day 3 | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Skin: Positive change, Day 4 | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Heart: Negative change, Day 4 | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Heart: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Negative change, Day 2 | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Negative change, Day 4 | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Eyes: Positive change, Day 2 | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Negative change, Day 4 | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Throat: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Positive change, Day 2 | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Eyes: Negative change, Day 3 | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Skin: Positive change, Day 8/discharge | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Positive change, Day 8/discharge | 1 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Skin: Positive change, Day 4 | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Head: Negative change, Day 4 | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Positive change, Day 3 | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Negative change, Day 3 | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Skin: Positive change, Day 8/discharge | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Heart: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Neurological: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Positive change, Day 4 | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Neurological: Positive change, Day 2 | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Negative change, Day 4 | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Heart: Negative change, Day 3 | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Negative change, Day 4 | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Positive change, Day 8/discharge | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Abdomen: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Eyes: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Eyes: Positive change, Day 2 | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Eyes: Positive change, Day 8/discharge | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Negative change, Day 2 | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Negative change, Day 2 | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Throat: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Positive change, Day 2 | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Heart: Negative change, Day 4 | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Neurological: Positive change, Day 3 | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Positive change, Day 8/discharge | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Heart: Negative change, Day 2 | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Eyes: Negative change, Day 3 | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Neurological: Positive change, Day 4 | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Skin: Positive change, Day 2 | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Head: Positive change, Day 8/discharge | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Head: Negative change, Day 2 | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Head: Negative change, Day 2 | 1 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Positive change, Day 3 | 0 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Skin: Positive change, Day 2 | 1 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Head: Negative change, Day 4 | 1 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Negative change, Day 4 | 1 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Neurological: Positive change, Day 4 | 1 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Head: Positive change, Day 8/discharge | 0 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Positive change, Day 4 | 0 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Positive change, Day 2 | 0 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Negative change, Day 4 | 0 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Heart: Negative change, Day 2 | 0 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Eyes: Positive change, Day 2 | 0 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Negative change, Day 8/discharge | 1 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Throat: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Heart: Negative change, Day 3 | 1 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Negative change, Day 3 | 1 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Heart: Negative change, Day 4 | 1 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Eyes: Negative change, Day 8/discharge | 1 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Positive change, Day 8/discharge | 0 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Negative change, Day 8/discharge | 1 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Heart: Negative change, Day 8/discharge | 1 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Neurological: Negative change, Day 8/discharge | 1 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Positive change, Day 8/discharge | 0 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Skin: Positive change, Day 8/discharge | 2 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Abdomen: Negative change, Day 8/discharge | 1 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Skin: Positive change, Day 4 | 1 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Negative change, Day 2 | 1 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Eyes: Positive change, Day 8/discharge | 1 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Neurological: Positive change, Day 3 | 0 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Neurological: Positive change, Day 2 | 0 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Negative change, Day 2 | 0 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Eyes: Negative change, Day 3 | 1 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Negative change, Day 4 | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Positive change, Day 8/discharge | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Neurological: Positive change, Day 4 | 2 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Eyes: Negative change, Day 3 | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Eyes: Negative change, Day 8/discharge | 1 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Eyes: Positive change, Day 2 | 1 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Eyes: Positive change, Day 8/discharge | 1 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Head: Negative change, Day 2 | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Head: Negative change, Day 4 | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Skin: Positive change, Day 2 | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Head: Positive change, Day 8/discharge | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Heart: Negative change, Day 2 | 1 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Heart: Negative change, Day 3 | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Heart: Negative change, Day 4 | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Heart: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Negative change, Day 2 | 1 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Skin: Positive change, Day 4 | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Negative change, Day 4 | 1 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Negative change, Day 8/discharge | 1 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Throat: Negative change, Day 8/discharge | 1 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Positive change, Day 2 | 1 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Positive change, Day 8/discharge | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Neurological: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Abdomen: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Skin: Positive change, Day 8/discharge | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Negative change, Day 2 | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Neurological: Positive change, Day 2 | 1 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Neurological: Positive change, Day 3 | 1 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Negative change, Day 3 | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Positive change, Day 3 | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Positive change, Day 4 | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Neurological: Positive change, Day 4 | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Neurological: Positive change, Day 3 | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Abdomen: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Positive change, Day 8/discharge | 1 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Positive change, Day 2 | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Positive change, Day 8/discharge | 1 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Negative change, Day 3 | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Skin: Positive change, Day 4 | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Negative change, Day 4 | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Lungs: Negative change, Day 2 | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Heart: Negative change, Day 8/discharge | 1 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Negative change, Day 4 | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Heart: Negative change, Day 4 | 1 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Heart: Negative change, Day 3 | 1 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Heart: Negative change, Day 2 | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Positive change, Day 4 | 1 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Skin: Positive change, Day 2 | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Head: Positive change, Day 8/discharge | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Head: Negative change, Day 4 | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Head: Negative change, Day 2 | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Eyes: Negative change, Day 3 | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Positive change, Day 3 | 1 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Eyes: Positive change, Day 8/discharge | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Eyes: Positive change, Day 2 | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Eyes: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Neurological: Positive change, Day 2 | 1 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Throat: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Skin: Positive change, Day 8/discharge | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Neurological: Negative change, Day 8/discharge | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Changes From Baseline in Physical Examination | Extremities: Negative change, Day 2 | 0 Participants |
Primary
Number of Participants With Electrocardiogram (ECG) Qualitative Results
The electrocardiogram (ECG) results over time were compared to baseline and assessed by the investigator as less abnormal, no significant change, or more abnormal.
Time frame: Baseline (pre-dose), Day 2, Day 4, Day 8/discharge
Population: All participants who received the treatment of PF-05230907. Number Analyzed represents the number of participants evaluable for each specified category.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 8/discharge | No significant change | 2 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 8/discharge | More abnormal | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 2 | More abnormal | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 4 | More abnormal | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 8/discharge | Less abnormal | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 4 | No significant change | 3 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 2 | No significant change | 3 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 2 | Less abnormal | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 4 | Less abnormal | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 8/discharge | More abnormal | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 4 | More abnormal | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 2 | No significant change | 3 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 2 | More abnormal | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 2 | Less abnormal | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 8/discharge | No significant change | 2 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 4 | Less abnormal | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 8/discharge | Less abnormal | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 4 | No significant change | 3 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 2 | No significant change | 3 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 4 | More abnormal | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 4 | Less abnormal | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 8/discharge | No significant change | 3 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 8/discharge | More abnormal | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 2 | More abnormal | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 8/discharge | Less abnormal | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 4 | No significant change | 3 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 2 | Less abnormal | 0 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 4 | More abnormal | 0 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 2 | Less abnormal | 0 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 2 | No significant change | 6 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 2 | More abnormal | 0 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 4 | Less abnormal | 0 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 4 | No significant change | 6 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 8/discharge | Less abnormal | 2 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 8/discharge | No significant change | 4 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 8/discharge | More abnormal | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 4 | No significant change | 2 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 4 | Less abnormal | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 8/discharge | Less abnormal | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 2 | More abnormal | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 8/discharge | More abnormal | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 8/discharge | No significant change | 2 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 2 | No significant change | 3 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 2 | Less abnormal | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 4 | More abnormal | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 2 | Less abnormal | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 4 | Less abnormal | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 4 | More abnormal | 1 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 8/discharge | More abnormal | 1 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 8/discharge | No significant change | 2 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 8/discharge | Less abnormal | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 2 | More abnormal | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 4 | No significant change | 2 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Electrocardiogram (ECG) Qualitative Results | Day 2 | No significant change | 3 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (AEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. For the respective event to count as a treatment-emergent AE, onset or worsening of the event must have occurred following treatment with PF-05230907 and during the interval between Day 1 dosing through Day 8.
Time frame: Day 1 through day of discharge (Day 8)
Population: All participants who received the treatment of PF-05230907.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Treatment-Emergent Adverse Events (AEs) | 2 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) | 3 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) | 3 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) | 5 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) | 3 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Treatment-Emergent Adverse Events (AEs) | 3 Participants |
Primary
Number of Participants With Treatment-Emergent Laboratory Abnormalities
Laboratory safety parameters included hematology, blood chemistry, prothrombin time/international normalized ratio (PT/INR), fibrinogen, antithrombin III (ATIII), Protein S level, Protein C activity, cardiac troponin I, D-dimer, and urinalysis. The number of participants with laboratory test abnormalities meeting specified criteria without regard to baseline abnormality was assessed. Any abnormalities occurring after the administration of treatment and increasing in severity from baseline value were counted as treatment-emergent.
Time frame: Day 1 through Day 8 (or discharge) for D-dimer laboratory test and urinalysis; Day 1 through Day 4 for all other laboratory tests
Population: All participants who received the treatment of PF-05230907.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Treatment-Emergent Laboratory Abnormalities | 3 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Treatment-Emergent Laboratory Abnormalities | 3 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Treatment-Emergent Laboratory Abnormalities | 3 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Treatment-Emergent Laboratory Abnormalities | 6 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Treatment-Emergent Laboratory Abnormalities | 3 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Treatment-Emergent Laboratory Abnormalities | 3 Participants |
Primary
Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; or was life threatening (immediate risk of death); or required inpatient hospitalization or prolongation of existing hospitalization; or resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or resulted in congenital anomaly/birth defect. Any such events occurring following the start of treatment or increasing in severity were counted as treatment-emergent.
Time frame: Day 1 through follow-up visit (Day 43)
Population: All participants who received the treatment of PF-05230907.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | 1 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | 1 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | 2 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | 2 Participants |
Primary
Number of Participants With Treatment-Emergent Thromboembolic and/or Ischemic Events (TIEs)
Thromboembolic and/or ischemic events (TIEs) were defined as any of the following events: disseminated intravascular coagulation (Grade \[Gr\]\>=3); acute coronary syndrome (Gr \>=3); cardiac arrest (Gr \>=4); myocardial infarction (Gr \>=3); Cardiac troponin I increased (Gr 3); ischemia cerebrovascular (Gr \>=1 and associated with lesion\[s\]); portal vein thrombosis (Gr \>=2); ischemic stroke (Gr \>=1 and associated with lesion\[s\]); transient ischemic attacks (Gr 2); purpura (Gr \>=2); superior vena cava syndrome (Gr \>=1); thromboembolic event (Gr \>=2); visceral arterial ischemia (Gr \>=2); peripheral arterial ischemia (Gr \>=3). TIEs were graded based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For the respective event to count as a treatment-emergent TIE, onset or worsening of the event must have occurred following treatment with PF-05230907 and during the interval between Day 1 dosing through Day 8.
Time frame: Day 1 through day of discharge (Day 8)
Population: All participants who received the treatment of PF-05230907.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Treatment-Emergent Thromboembolic and/or Ischemic Events (TIEs) | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Treatment-Emergent Thromboembolic and/or Ischemic Events (TIEs) | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Treatment-Emergent Thromboembolic and/or Ischemic Events (TIEs) | 0 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Treatment-Emergent Thromboembolic and/or Ischemic Events (TIEs) | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Treatment-Emergent Thromboembolic and/or Ischemic Events (TIEs) | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Treatment-Emergent Thromboembolic and/or Ischemic Events (TIEs) | 2 Participants |
Secondary
Maximum Changes From Baseline for Activated Partial Thromboplastin Time (aPTT)
Maximum changes from baseline were calculated for activated partial thromboplastin time (aPTT) after dosing with PF-05230907 through Day 2.
Time frame: Baseline (pre-dose), Day 2
Population: All treated participants who had at least 1 measurement of pharmacodynamic parameters of interest.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Maximum Changes From Baseline for Activated Partial Thromboplastin Time (aPTT) | -8.53 seconds (sec) | Standard Deviation 3.25 |
| PF-05230907 8 mcg/kg | Maximum Changes From Baseline for Activated Partial Thromboplastin Time (aPTT) | -12.17 seconds (sec) | Standard Deviation 1.06 |
| PF-05230907 12 mcg/kg | Maximum Changes From Baseline for Activated Partial Thromboplastin Time (aPTT) | -8.47 seconds (sec) | Standard Deviation 1.79 |
| PF-05230907 19 mcg/kg | Maximum Changes From Baseline for Activated Partial Thromboplastin Time (aPTT) | -8.76 seconds (sec) | Standard Deviation 4.859 |
| PF-05230907 24 mcg/kg | Maximum Changes From Baseline for Activated Partial Thromboplastin Time (aPTT) | -5.00 seconds (sec) | Standard Deviation 5.522 |
| PF-05230907 30 mcg/kg | Maximum Changes From Baseline for Activated Partial Thromboplastin Time (aPTT) | -12.03 seconds (sec) | Standard Deviation 4.574 |
Secondary
Maximum Changes From Baseline for Prothrombin Fragment 1+2 (PF1+2)
Maximum changes from baseline were calculated for prothrombin fragment 1+2 (PF1+2) after dosing with PF-05230907 through Day 2.
Time frame: Baseline (pre-dose), Day 2
Population: All treated participants who had at least 1 measurement of pharmacodynamic parameters of interest.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Maximum Changes From Baseline for Prothrombin Fragment 1+2 (PF1+2) | -163.7 picomoles per liter (pmol/L) | Standard Deviation 390.08 |
| PF-05230907 8 mcg/kg | Maximum Changes From Baseline for Prothrombin Fragment 1+2 (PF1+2) | 2823.7 picomoles per liter (pmol/L) | Standard Deviation 137.25 |
| PF-05230907 12 mcg/kg | Maximum Changes From Baseline for Prothrombin Fragment 1+2 (PF1+2) | 1286.0 picomoles per liter (pmol/L) | Standard Deviation 1331.09 |
| PF-05230907 19 mcg/kg | Maximum Changes From Baseline for Prothrombin Fragment 1+2 (PF1+2) | 492.6 picomoles per liter (pmol/L) | Standard Deviation 1445.6 |
| PF-05230907 24 mcg/kg | Maximum Changes From Baseline for Prothrombin Fragment 1+2 (PF1+2) | 1773.7 picomoles per liter (pmol/L) | Standard Deviation 1472.95 |
| PF-05230907 30 mcg/kg | Maximum Changes From Baseline for Prothrombin Fragment 1+2 (PF1+2) | 354.3 picomoles per liter (pmol/L) | Standard Deviation 501.75 |
Secondary
Number of Participants With Anti-Drug Antibody (ADA) Production
Participants with anti-drug antibody (ADA) production were those with at least 1 positive result from Day 1 through follow-up visit (Day 43 and/or Day 91). ADA positive: titer value \>=1.88.
Time frame: Day 1 up to follow-up visit (Day 43 and/or Day 91)
Population: All treated participants who had at least 1 measurement of post-treatment immunogenicity parameters of interest.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Anti-Drug Antibody (ADA) Production | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Anti-Drug Antibody (ADA) Production | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Anti-Drug Antibody (ADA) Production | 0 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Anti-Drug Antibody (ADA) Production | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Anti-Drug Antibody (ADA) Production | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Anti-Drug Antibody (ADA) Production | 0 Participants |
Secondary
Number of Participants With Depletion of Coagulation Factor X
Depletion of coagulation factor X was defined as \>50% reduction relative to baseline (pre-dose).
Time frame: Baseline (pre-dose), Day 43, Day 91
Population: All participants who received the treatment of PF-05230907. Number Analyzed represents the number of participants evaluable for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Depletion of Coagulation Factor X | Day 43 | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Depletion of Coagulation Factor X | Day 91 | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Depletion of Coagulation Factor X | Day 43 | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Depletion of Coagulation Factor X | Day 91 | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Depletion of Coagulation Factor X | Day 43 | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Depletion of Coagulation Factor X | Day 91 | 0 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Depletion of Coagulation Factor X | Day 43 | 0 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Depletion of Coagulation Factor X | Day 91 | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Depletion of Coagulation Factor X | Day 43 | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Depletion of Coagulation Factor X | Day 91 | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Depletion of Coagulation Factor X | Day 43 | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Depletion of Coagulation Factor X | Day 91 | 0 Participants |
Secondary
Number of Participants With Neutralizing Antibody (NAb) Production
ADA positive samples were planned to be further characterized for neutralizing antibody (NAb). Participants with NAb production were those with at least 1 positive result from Day 1 through follow-up visit (Day 43 and/or Day 91). As all ADA samples were negative (titer value \<1.88), NAb analysis was not conducted.
Time frame: Day 1 up to follow-up visit (Day 43 and/or Day 91)
Population: All treated participants who had at least 1 measurement of post-treatment immunogenicity parameters of interest.
Other Pre-specified
Change From Baseline in Intracerebral Hemorrhage (ICH) Volume at 24 Hours
Change from baseline in intracerebral hemorrhage (ICH) volume was calculated at 24 hours.
Time frame: Baseline (pre-dose), 24 hours
Population: All participants who received the treatment of PF-05230907.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Change From Baseline in Intracerebral Hemorrhage (ICH) Volume at 24 Hours | -0.297 centimeter (cm)^3 | Standard Deviation 0.3761 |
| PF-05230907 8 mcg/kg | Change From Baseline in Intracerebral Hemorrhage (ICH) Volume at 24 Hours | 0.410 centimeter (cm)^3 | Standard Deviation 2.1554 |
| PF-05230907 12 mcg/kg | Change From Baseline in Intracerebral Hemorrhage (ICH) Volume at 24 Hours | 12.137 centimeter (cm)^3 | Standard Deviation 10.9207 |
| PF-05230907 19 mcg/kg | Change From Baseline in Intracerebral Hemorrhage (ICH) Volume at 24 Hours | 1.190 centimeter (cm)^3 | Standard Deviation 2.1099 |
| PF-05230907 24 mcg/kg | Change From Baseline in Intracerebral Hemorrhage (ICH) Volume at 24 Hours | 1.130 centimeter (cm)^3 | Standard Deviation 1.7385 |
| PF-05230907 30 mcg/kg | Change From Baseline in Intracerebral Hemorrhage (ICH) Volume at 24 Hours | 0.097 centimeter (cm)^3 | Standard Deviation 1.8781 |
Other Pre-specified
Health Resource Utilization Surrogate Measures - Maximum Duration
Maximum duration for 4 types of hospital or health care unit: Intensive Care Unit (ICU), general ward, rehabilitation center, and other hospital units. This was an exploratory endpoint to evaluate information for designing future studies, which were no longer planned.
Time frame: Day 1 up to Day 91
Population: All participants who received the treatment of PF-05230907. Number Analyzed represents the number of participants evaluable for each specified category.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Health Resource Utilization Surrogate Measures - Maximum Duration | Other hospital unit | 4 days |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Health Resource Utilization Surrogate Measures - Maximum Duration | ICU | 2 days |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Health Resource Utilization Surrogate Measures - Maximum Duration | Rehabilitation center | 75 days |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Health Resource Utilization Surrogate Measures - Maximum Duration | General ward | 1 days |
| PF-05230907 8 mcg/kg | Health Resource Utilization Surrogate Measures - Maximum Duration | Other hospital unit | 3 days |
| PF-05230907 8 mcg/kg | Health Resource Utilization Surrogate Measures - Maximum Duration | General ward | 5 days |
| PF-05230907 8 mcg/kg | Health Resource Utilization Surrogate Measures - Maximum Duration | ICU | 2 days |
| PF-05230907 8 mcg/kg | Health Resource Utilization Surrogate Measures - Maximum Duration | Rehabilitation center | 75 days |
| PF-05230907 12 mcg/kg | Health Resource Utilization Surrogate Measures - Maximum Duration | Other hospital unit | 7 days |
| PF-05230907 12 mcg/kg | Health Resource Utilization Surrogate Measures - Maximum Duration | ICU | 1 days |
| PF-05230907 12 mcg/kg | Health Resource Utilization Surrogate Measures - Maximum Duration | Rehabilitation center | 40.5 days |
| PF-05230907 12 mcg/kg | Health Resource Utilization Surrogate Measures - Maximum Duration | General ward | 16.5 days |
| PF-05230907 19 mcg/kg | Health Resource Utilization Surrogate Measures - Maximum Duration | General ward | 7 days |
| PF-05230907 19 mcg/kg | Health Resource Utilization Surrogate Measures - Maximum Duration | Other hospital unit | 24 days |
| PF-05230907 19 mcg/kg | Health Resource Utilization Surrogate Measures - Maximum Duration | ICU | 30 days |
| PF-05230907 19 mcg/kg | Health Resource Utilization Surrogate Measures - Maximum Duration | Rehabilitation center | 30.5 days |
| PF-05230907 24 mcg/kg | Health Resource Utilization Surrogate Measures - Maximum Duration | Other hospital unit | 3.5 days |
| PF-05230907 24 mcg/kg | Health Resource Utilization Surrogate Measures - Maximum Duration | ICU | 17.5 days |
| PF-05230907 24 mcg/kg | Health Resource Utilization Surrogate Measures - Maximum Duration | Rehabilitation center | 79 days |
| PF-05230907 24 mcg/kg | Health Resource Utilization Surrogate Measures - Maximum Duration | General ward | 31.5 days |
| PF-05230907 30 mcg/kg | Health Resource Utilization Surrogate Measures - Maximum Duration | Rehabilitation center | 20 days |
| PF-05230907 30 mcg/kg | Health Resource Utilization Surrogate Measures - Maximum Duration | ICU | 1 days |
| PF-05230907 30 mcg/kg | Health Resource Utilization Surrogate Measures - Maximum Duration | General ward | 26 days |
Other Pre-specified
Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS)
The National Institute of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The total NIHSS score range is from 0 (normal) to 42 (severe impairment), with higher values indicating greater level of neurological impairment.
Time frame: Screening, Day 1, Day 2, Day 4, Day 43, and Day 91
Population: All participants who received the treatment of PF-05230907. Number Analyzed represents the number of participants evaluable for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Screening | 11.7 units on a scale | Standard Deviation 7.37 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 1 | 11.3 units on a scale | Standard Deviation 6.81 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 2 | 10.0 units on a scale | Standard Deviation 12.73 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 4 | 5.7 units on a scale | Standard Deviation 8.08 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 43 | 1.0 units on a scale | Standard Deviation 1 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 91 | 0.7 units on a scale | Standard Deviation 0.58 |
| PF-05230907 8 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 1 | 14.0 units on a scale | Standard Deviation 6.24 |
| PF-05230907 8 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 4 | 12.7 units on a scale | Standard Deviation 8.14 |
| PF-05230907 8 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 91 | 1.5 units on a scale | Standard Deviation 0.71 |
| PF-05230907 8 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Screening | 10.7 units on a scale | Standard Deviation 8.62 |
| PF-05230907 8 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 2 | 16.3 units on a scale | Standard Deviation 6.51 |
| PF-05230907 8 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 43 | 8.3 units on a scale | Standard Deviation 8.39 |
| PF-05230907 12 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 91 | 3.5 units on a scale | Standard Deviation 3.54 |
| PF-05230907 12 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 43 | 4.5 units on a scale | Standard Deviation 6.36 |
| PF-05230907 12 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 4 | 16.0 units on a scale | Standard Deviation 10.82 |
| PF-05230907 12 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 2 | 16.0 units on a scale | Standard Deviation 10.82 |
| PF-05230907 12 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Screening | 15.3 units on a scale | Standard Deviation 10.6 |
| PF-05230907 12 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 1 | 15.3 units on a scale | Standard Deviation 10.6 |
| PF-05230907 19 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 4 | 9.8 units on a scale | Standard Deviation 5.98 |
| PF-05230907 19 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 1 | 15.2 units on a scale | Standard Deviation 6.37 |
| PF-05230907 19 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 2 | 12.3 units on a scale | Standard Deviation 5.43 |
| PF-05230907 19 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 91 | 5.2 units on a scale | Standard Deviation 5.07 |
| PF-05230907 19 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 43 | 4.4 units on a scale | Standard Deviation 5.59 |
| PF-05230907 19 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Screening | 15.7 units on a scale | Standard Deviation 4.68 |
| PF-05230907 24 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Screening | 17.0 units on a scale | Standard Deviation 2.65 |
| PF-05230907 24 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 43 | 15.5 units on a scale | Standard Deviation 4.95 |
| PF-05230907 24 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 1 | 16.0 units on a scale | Standard Deviation 2.83 |
| PF-05230907 24 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 2 | 16.0 units on a scale | Standard Deviation 4.24 |
| PF-05230907 24 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 4 | 13.5 units on a scale | Standard Deviation 2.12 |
| PF-05230907 24 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 91 | 13.5 units on a scale | Standard Deviation 7.78 |
| PF-05230907 30 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 4 | 14.7 units on a scale | Standard Deviation 6.03 |
| PF-05230907 30 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 2 | 14.3 units on a scale | Standard Deviation 5.86 |
| PF-05230907 30 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 43 | 5.0 units on a scale | Standard Deviation 1.41 |
| PF-05230907 30 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 91 | 2.0 units on a scale | Standard Deviation 2.83 |
| PF-05230907 30 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Day 1 | 13.7 units on a scale | Standard Deviation 7.51 |
| PF-05230907 30 mcg/kg | Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) | Screening | 13.7 units on a scale | Standard Deviation 7.51 |
Other Pre-specified
Number of Participants With Anti-Chinese Hamster Ovary (CHO) Protein Antibody Production
Participants with anti-Chinese hamster ovary (CHO) antibody production were those with positive results. Positive: titer value \>=2.00.
Time frame: Day 1, Day 43
Population: All treated participants who had at least 1 measurement of post-treatment immunogenicity parameters of interest. Number Analyzed represents the number of participants evaluable for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Anti-Chinese Hamster Ovary (CHO) Protein Antibody Production | Day 1 | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Anti-Chinese Hamster Ovary (CHO) Protein Antibody Production | Day 43 | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Anti-Chinese Hamster Ovary (CHO) Protein Antibody Production | Day 1 | 1 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Anti-Chinese Hamster Ovary (CHO) Protein Antibody Production | Day 43 | 1 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Anti-Chinese Hamster Ovary (CHO) Protein Antibody Production | Day 1 | 2 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Anti-Chinese Hamster Ovary (CHO) Protein Antibody Production | Day 43 | 2 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Anti-Chinese Hamster Ovary (CHO) Protein Antibody Production | Day 1 | 2 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Anti-Chinese Hamster Ovary (CHO) Protein Antibody Production | Day 43 | 3 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Anti-Chinese Hamster Ovary (CHO) Protein Antibody Production | Day 1 | 2 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Anti-Chinese Hamster Ovary (CHO) Protein Antibody Production | Day 43 | 2 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Anti-Chinese Hamster Ovary (CHO) Protein Antibody Production | Day 1 | 1 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Anti-Chinese Hamster Ovary (CHO) Protein Antibody Production | Day 43 | 2 Participants |
Other Pre-specified
Number of Participants With Anti-Paired Basic Amino Acid Cleaving Enzyme (PACE) Furin Antibody Production
Participants with anti-paired basic amino acid cleaving enzyme (PACE) antibody production were those with positive results. Positive: titer value \>=2.00.
Time frame: Day 1, Day 43
Population: All treated participants who had at least 1 measurement of post-treatment immunogenicity parameters of interest. Number Analyzed represents the number of participants evaluable for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Anti-Paired Basic Amino Acid Cleaving Enzyme (PACE) Furin Antibody Production | Day 43 | 0 Participants |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | Number of Participants With Anti-Paired Basic Amino Acid Cleaving Enzyme (PACE) Furin Antibody Production | Day 1 | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Anti-Paired Basic Amino Acid Cleaving Enzyme (PACE) Furin Antibody Production | Day 43 | 0 Participants |
| PF-05230907 8 mcg/kg | Number of Participants With Anti-Paired Basic Amino Acid Cleaving Enzyme (PACE) Furin Antibody Production | Day 1 | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Anti-Paired Basic Amino Acid Cleaving Enzyme (PACE) Furin Antibody Production | Day 43 | 0 Participants |
| PF-05230907 12 mcg/kg | Number of Participants With Anti-Paired Basic Amino Acid Cleaving Enzyme (PACE) Furin Antibody Production | Day 1 | 0 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Anti-Paired Basic Amino Acid Cleaving Enzyme (PACE) Furin Antibody Production | Day 43 | 0 Participants |
| PF-05230907 19 mcg/kg | Number of Participants With Anti-Paired Basic Amino Acid Cleaving Enzyme (PACE) Furin Antibody Production | Day 1 | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Anti-Paired Basic Amino Acid Cleaving Enzyme (PACE) Furin Antibody Production | Day 1 | 0 Participants |
| PF-05230907 24 mcg/kg | Number of Participants With Anti-Paired Basic Amino Acid Cleaving Enzyme (PACE) Furin Antibody Production | Day 43 | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Anti-Paired Basic Amino Acid Cleaving Enzyme (PACE) Furin Antibody Production | Day 43 | 0 Participants |
| PF-05230907 30 mcg/kg | Number of Participants With Anti-Paired Basic Amino Acid Cleaving Enzyme (PACE) Furin Antibody Production | Day 1 | 0 Participants |
Other Pre-specified
PF-05230907 Concentration in Plasma
Time frame: Day 1 pre-dose, 5 and 45 minutes post-dose
Population: All treated participants who had at least 1 measurement of PF-05230907 concentration. Number Analyzed represents the number of participants evaluable for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | PF-05230907 Concentration in Plasma | 5 minutes post-dose | 11.90 nanogram per milliliter (ng/mL) | Standard Deviation 13.359 |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | PF-05230907 Concentration in Plasma | Pre-dose | NA nanogram per milliliter (ng/mL) | — |
| PF-05230907 5 Microgram Per Kilogram (mcg/kg) | PF-05230907 Concentration in Plasma | 45 minutes post-dose | 1.377 nanogram per milliliter (ng/mL) | Standard Deviation 1.1935 |
| PF-05230907 8 mcg/kg | PF-05230907 Concentration in Plasma | 45 minutes post-dose | 2.460 nanogram per milliliter (ng/mL) | Standard Deviation 0.32527 |
| PF-05230907 8 mcg/kg | PF-05230907 Concentration in Plasma | Pre-dose | NA nanogram per milliliter (ng/mL) | — |
| PF-05230907 12 mcg/kg | PF-05230907 Concentration in Plasma | 5 minutes post-dose | 34.63 nanogram per milliliter (ng/mL) | Standard Deviation 30.731 |
| PF-05230907 12 mcg/kg | PF-05230907 Concentration in Plasma | Pre-dose | 17.46 nanogram per milliliter (ng/mL) | Standard Deviation 28.121 |
| PF-05230907 12 mcg/kg | PF-05230907 Concentration in Plasma | 45 minutes post-dose | 17.21 nanogram per milliliter (ng/mL) | Standard Deviation 23.815 |
| PF-05230907 19 mcg/kg | PF-05230907 Concentration in Plasma | 5 minutes post-dose | 39.82 nanogram per milliliter (ng/mL) | Standard Deviation 28.393 |
| PF-05230907 19 mcg/kg | PF-05230907 Concentration in Plasma | Pre-dose | 2.382 nanogram per milliliter (ng/mL) | Standard Deviation 3.418 |
| PF-05230907 19 mcg/kg | PF-05230907 Concentration in Plasma | 45 minutes post-dose | 6.938 nanogram per milliliter (ng/mL) | Standard Deviation 1.607 |
| PF-05230907 24 mcg/kg | PF-05230907 Concentration in Plasma | 5 minutes post-dose | 35.60 nanogram per milliliter (ng/mL) | Standard Deviation 21.072 |
| PF-05230907 24 mcg/kg | PF-05230907 Concentration in Plasma | Pre-dose | NA nanogram per milliliter (ng/mL) | — |
| PF-05230907 24 mcg/kg | PF-05230907 Concentration in Plasma | 45 minutes post-dose | 2.490 nanogram per milliliter (ng/mL) | — |
| PF-05230907 30 mcg/kg | PF-05230907 Concentration in Plasma | Pre-dose | NA nanogram per milliliter (ng/mL) | — |
| PF-05230907 30 mcg/kg | PF-05230907 Concentration in Plasma | 45 minutes post-dose | 4.657 nanogram per milliliter (ng/mL) | Standard Deviation 1.6342 |
| PF-05230907 30 mcg/kg | PF-05230907 Concentration in Plasma | 5 minutes post-dose | 41.17 nanogram per milliliter (ng/mL) | Standard Deviation 23.756 |