| Primary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Supine blood pressure (BP) was measured with the participant's arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg) after 5 minutes of rest. The same arm (preferably the dominant arm) was to be used throughout the study. | The safety population included all enrolled participants who received the study drug. | Posted | | Mean | Standard Deviation | mmHg | | Baseline, Day 2, Day 3, and Day 15 | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG003 | PF-05280602 18.0 mcg/kg | PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG004 | PF-05280602 30.0 mcg/kg | PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. |
| | | Title | Denominators | Categories |
|---|
| SBP: Baseline | | | Title | Measurements |
|---|
| - OG000122.0± NAAs only 1 participant was analyzed, standard deviation was not calculated.
- OG001130.2± 7.14
- OG002120.2± 25.41
|
|
| |
| Primary | Change From Baseline in Body Weight | | The safety population included all enrolled participants who received the study drug. | Posted | | Mean | Standard Deviation | kilograms (kg) | | Baseline, Day 2, Day 3, and Day 15 | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG003 | PF-05280602 18.0 mcg/kg | PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG004 |
|
| Primary | Change From Baseline in Body Temperature | Body temperature was measured by mouth (oral) or ear (tympanic). A temperature greater than 38.5 degree Celsius was considered a fever. | The safety population included all enrolled participants who received the study drug. | Posted | | Mean | Standard Deviation | degree Celcius | | Baseline, Day 2, Day 3, and Day 15 | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG003 | PF-05280602 18.0 mcg/kg | PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. |
|
| Primary | Change From Baseline in Respiration Rate | Respiration rate measured as respirations per minute (resp/min). | The safety population included all enrolled participants who received the study drug. | Posted | | Mean | Standard Deviation | resp/min | | Baseline, Day 2, Day 3, and Day 15 | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG003 | PF-05280602 18.0 mcg/kg | PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. |
|
| Primary | Change From Baseline in Supine Pulse Rate | Change from baseline is the vital sign value at Day 2, Day 3, and Day 15 minus vital sign value at baseline. | The safety population included all enrolled participants who received the study drug. | Posted | | Mean | Standard Deviation | beats per minute (bpm) | | Baseline, Day 2, Day 3, and Day 15 | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG003 | PF-05280602 18.0 mcg/kg | PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. |
|
| Primary | Number of Participants With Changes Since Previous Physical Examination | Physical examinations were conducted by a physician, trained physician's assistant, or nurse practitioner. A complete physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, genitourinary, gastrointestinal, musculoskeletal, and neurological systems. The limited or abbreviated physical examination focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. | The safety population included all enrolled participants who received the study drug. | Posted | | Number | | participants | | Baseline (Day 0), Day 1, Day 2, Day 3, Day 15 | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. |
|
| Primary | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings | ECG findings of potential clinical concern were: PR interval greater than or equal to (>=)300 milliseconds (msec), >=25% increase from baseline for baseline values >200 msec, >=50% increase from baseline for baseline values less than or equal to (<=)200 msec; QRS complex >=140 msec or >=50% increase from baseline; QTcF interval (Fridericia's correction) >=450 msec or >=30 msec increase from baseline. | The safety population included all enrolled participants who received the study drug. | Posted | | Number | | participants | | Baseline through Day 15 | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. |
|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs (Except Hemophilia AEs) | An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 15 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. | The safety population included all enrolled participants who received the study drug. | Posted | | Number | | participants | | Baseline through Day 60 | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg |
|
| Primary | Number of Participants With Treatment-Emergent Hemophilia AEs and Withdrawals Due to Hemophilia AEs | Hemophilia AEs included spontaneous (no known contributing factor) and traumatic (known or presumed contributing factor/reason) bleeding episodes. | The safety population included all enrolled participants who received the study drug. | Posted | | Number | | participants | | Baseline through Day 60 | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG003 | PF-05280602 18.0 mcg/kg | |
|
| Primary | Number of Treatment-Emergent AEs and SAEs by Severity (Except Hemophilia AEs) | AE severity were graded as mild, moderate, or severe. Mild severity AEs do not interfere with the participant's usual function. Moderate AEs interfere to some extent with the participant's usual function. Severe AEs interfere significantly with the participant's usual function. | The safety population included all enrolled participants who received the study drug. | Posted | | Number | | adverse events | | Baseline through Day 60 | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG003 |
|
| Primary | Number of Treatment-Emergent Hemophilia AEs by Severity | Mild severity AEs do not interfere with the participant's usual function. Moderate AEs interfere to some extent with the participant's usual function. Severe AEs interfere significantly with the participant's usual function. | The safety population included all enrolled participants who received the study drug. | Posted | | Number | | adverse events | | Baseline through Day 60 | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG003 | PF-05280602 18.0 mcg/kg |
|
| Primary | Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude | Troponin-T is a cardiac marker for the evaluation of possible cardiovascular injury. Troponin-T levels of potential clinical concern are values >1.5 times the upper limit of normal (1.5X ULN) or >=2.5X ULN. | The safety population included all enrolled participants who received the study drug. | Posted | | Number | | participants | | Baseline through Day 15 | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG003 | PF-05280602 18.0 mcg/kg |
|
| Primary | Number of Participants With Treatment-Emergent Abnormal Anti-Thrombin III (ATIII) Levels by Magnitude | ATIII is a protein in the blood that blocks abnormal blood clots from forming. Low levels of ATIII can cause abnormal blood clots. ATIII levels of potential clinical concern are values <1X LLN and >1X ULN. | The safety population included all enrolled participants who received the study drug. | Posted | | Number | | participants | | Baseline through Day 3 | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG003 | PF-05280602 18.0 mcg/kg |
|
| Primary | Number of Participants With Treatment-Emergent Abnormal Tissue Factor Pathway Inhibitor (TFPI) Levels by Magnitude | TFPI is a polypeptide that can regulate blood coagulation. TFPI levels of potential clinical concern are values <1X LLN and >1X ULN. | The safety population included all enrolled participants who received the study drug. | Posted | | Number | | participants | | Baseline through Day 3 | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG003 | PF-05280602 18.0 mcg/kg | |
|
| Primary | Number of Participants With Treatment-Emergent Laboratory Test Abnormalities (Normal Baseline) | The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); chemistry (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, creatinine, blood urea nitrogen [BUN], glucose, uric acid, sodium, potassium, chloride, bicarbonate, calcium, albumin, total protein, creatine kinase); urinalysis (urine white blood cell [WBC], urine RBC); other (troponin T). | The safety population included all enrolled participants who received the study drug. | Posted | | Number | | participants | | Baseline through Day 15 | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg |
|
| Primary | Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria | Clinically significant findings for stopping rules are: hemoglobin <8 grams/deciliter (g/dL) or >20% decrease from normal baseline; WBC >20,000 cells/mm^3 or <1,500 decrease with normal baseline; platelets <100,000/mm^3 or >33% decrease from baseline; total bilirubin >1.5X ULN; AST or ALT >2.5X ULN; alkaline phosphatase >3X ULN; creatinine >1.5X baseline; BUN >31.0 mg/dL; glucose <0.6 or >1.5X reference range; uric acid > ULN; sodium >150 or <130 mEq/L; potassium >5.5 or <3.0 mEq/L; calcium >11.5 or <8.0 mg/dL; albumin <2.0 g/L; total protein <5.0 g/L; positive D-dimer at Day 15; PT prolonged by 3 seconds above baseline; ATIII < LLN and >20% decrease from baseline; troponin-T values above the reference range; fibrinogen <0.75X LLN or >25% decrease from baseline. | The safety population included all enrolled participants who received the study drug. | Posted | | Number | | participants | | Baseline through Day 15 | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. |
|
| Primary | Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity) | Assays for the determination of a positive immune response was performed. An antibody immune response was defined as a confirmed post-treatment positive ELISA result in combination with a negative baseline sample ELISA result. Positive antibody immune responses to PF-05280602 by ELISA was evaluated for cross reactivity to NovoSeven RT and to Factor VII. | The immunogenicity parameter population included enrolled and treated participants with at least 1 post-treatment anti-PF-05280602 antibody (ADA), PF-05280602 inhibitor, or Factor VII activity level determination. | Posted | | Number | | participants | | Baseline through Day 60 | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg |
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) | | The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose) | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG003 | PF-05280602 18.0 mcg/kg | PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. |
|
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose) | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG003 |
|
| Secondary | Terminal Elimination Half-Life (t1/2) | t1/2 is the time measured for the plasma concentration to decrease by one half. | The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest. | Posted | | Mean | Standard Deviation | hour | | Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose) | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG003 | PF-05280602 18.0 mcg/kg |
|
| Secondary | Incremental Recovery (IncRec) | IncRec is the maximum rise in plasma concentration per administered dose. | The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL/mcg/kg | | Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose) | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG003 | PF-05280602 18.0 mcg/kg |
|
| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | AUCinf is area under the plasma concentration-time curve from time 0 extrapolated to infinite time. | The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose) | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG003 |
|
| Secondary | Mean Residence Time (MRT) | MRT is AUMCinf/AUCinf, where AUMC is the area under the first moment curve. | The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest. | Posted | | Mean | Standard Deviation | hours | | Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose) | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG003 | PF-05280602 18.0 mcg/kg |
|
| Secondary | Volume of Distribution at Steady State (Vss) | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. | The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/kg | | Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose) | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. |
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| Secondary | Clearance (CL) | Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose is influenced by the fraction of the dose absorbed. | The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/hr/kg | | Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose) | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. |
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| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) | | The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest. | Posted | | Median | Full Range | hours | | Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose) | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG003 | PF-05280602 18.0 mcg/kg | PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. |
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| Secondary | Maximum Mean Decrease From Baseline in Prothrombin Time (PT) | PT measures how long it takes blood to clot. Maximum mean decrease from baseline at any time point was reported. | The safety population included all enrolled participants who received the study drug. | Posted | | Mean | Standard Deviation | seconds | | Baseline through Day 15 | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG003 | PF-05280602 18.0 mcg/kg | PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. |
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| Secondary | Maximum Mean Decrease From Baseline in Activated Partial Thromboplastin Time (aPTT) | aPTT is a blood test that characterizes blood coagulation. Maximum mean decrease from baseline at any time point was reported. | The safety population included all enrolled participants who received the study drug. | Posted | | Mean | Standard Deviation | seconds | | Baseline through Day 15 | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG003 | PF-05280602 18.0 mcg/kg | |
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| Secondary | Maximum Mean Increase From Baseline in Thrombin Anti-Thrombin (TAT) Complexes | TAT complex is a parameter of coagulation and fibrinolysis. The normal reference range of values for TAT is 1 to 4.1 mcg/L. Elevated TAT concentrations may signify predisposition to thrombosis. Maximum mean increase from baseline at any time point was reported. | The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure. | Posted | | Mean | Standard Deviation | mcg/L | | Baseline through Day 3 | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. |
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| Secondary | Maximum Mean Increase From Baseline in Prothrombin Fragments 1+2 | Prothrombin fragment 1+2 is a coagulation factor, released when prothrombin is cleaved by activated Factor X. Elevated plasma levels of prothrombin fragment 1+2 indicate high risk of thrombosis. Maximum mean increase from baseline at any time point was reported. | The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure. | Posted | | Mean | Standard Deviation | picomoles per liter (pmol/L) | | Baseline through Day 3 | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. |
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| Secondary | Maximum Mean Increase From Baseline in D-Dimers | D-dimer is an indicator of fibrin formation and its subsequent lysis and is a useful biomarker representing overall activation of blood coagulation. Maximum mean increase from baseline at any time point was reported. | The safety population included all enrolled participants who received the study drug. | Posted | | Mean | Standard Deviation | ng/mL | | Baseline through Day 15 | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG003 | PF-05280602 18.0 mcg/kg |
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| Secondary | Maximum Mean Increase From Baseline in Endogenous Thrombin Potential (ETP) | ETP was evaluated using a Thrombin Generation Assay (TGA), a validated automated ex-vivo assay that measures the ability of plasma to generate thrombin. Thrombin generation curves are generated and calculated using dedicated software. ETP is the area under the thrombin generation curve and represents the total amount of generated thrombin. Maximum mean increase from baseline at any time point was reported. | The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure. | Posted | | Mean | Standard Deviation | nanomolar*minute (nM*min) | | Baseline through Day 3 | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | |
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| Secondary | Maximum Mean Decrease From Baseline in Thrombin Generation Lag Time | The lag time is defined as the time to reach one sixth of the peak height and is a measure of the initiation phase. It is equivalent to the clotting time. Maximum mean decrease from baseline at any time point was reported. | The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure. | Posted | | Mean | Standard Deviation | minutes | | Baseline through Day 3 | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG003 |
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| Secondary | Maximum Mean Increase From Baseline in Peak Thrombin Generation | The peak height is defined as the maximum thrombin concentration produced. Maximum mean increase from baseline at any time point was reported. | The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure. | Posted | | Mean | Standard Deviation | Nanomolar (nM) | | Baseline through Day 3 | | | | ID | Title | Description |
|---|
| OG000 | PF-05280602 0.5 mcg/kg | PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg. | | OG001 | PF-05280602 4.5 mcg/kg | PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG002 | PF-05280602 9.0 mcg/kg | PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1. | | OG003 | PF-05280602 18.0 mcg/kg |
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