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The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of several blood thinner drugs on laboratory tests. The study also is evaluating the blood levels of PRT064445 given at different doses.
A randomized, double-blind, vehicle-controlled study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of intravenously administered PRT064445 after dosing to steady state with one of four direct/indirect factor Xa (fXa) inhibitors in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Module 2 (210 mg) | Experimental | 210 mg andexanet IV bolus administered over 7 minutes (~30 mg/min) |
|
| Module 2 (420 mg) | Experimental | 420 mg andexanet IV bolus administered over 14 minutes (~30 mg/min) |
|
| Module 2 (600 mg) | Experimental | 600 mg andexanet IV bolus administered over 20 minutes (~30 mg/min) |
|
| Module 2 (720 mg bolus + 240 mg infusion) | Experimental | 720 mg IV bolus administered over 24 minutes [~30 mg/min] followed by 240 mg continuous IV infusion [4 mg/min over 60 min)](streamdown:incomplete-link) |
|
| Module 2 (800 mg bolus + 960 mg infusion) | Experimental | 800 mg IV bolus administered over 26.7 minutes [~30 mg/min] followed by 960 mg continuous IV infusion [8 mg/min over 120 min] |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRT064445/Rivaroxaban | Combination Product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Percent Change From Baseline in Anti-fXa Activity at 2 Mins Following Andexanet/Placebo Administration | Anti-fXa activity was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Anti-fXa activity was measured using a commercial kit (Coamatic Heparin-82 33 9363, DiaPharma) | Baseline to 2 minutes following the end of andexanet/placebo administration |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Percent Change From Baseline in Thrombin Generation at 2 Mins Following Andexanet/Placebo Administration | Thrombin generation was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Thrombin generation was measured using a TF-initiated thrombin generation assay. | Baseline to 2 minutes following the end of andexanet/placebo administration |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32092140 | Derived | Lu G, Conley PB, Leeds JM, Karbarz MJ, Levy GG, Mathur VS, Castillo J, Crowther M, Curnutte JT. A phase 2 PK/PD study of andexanet alfa for reversal of rivaroxaban and edoxaban anticoagulation in healthy volunteers. Blood Adv. 2020 Feb 25;4(4):728-739. doi: 10.1182/bloodadvances.2019000885. |
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Rivaroxaban was administered orally at 20 mg once daily for 6 days to steady-state in an open label fashion. Subjects were then randomized to receive study treatment (andexanet or placebo) intravenously at different doses/dose regimens on Day 6, all bolus doses administered such that they ended at 3 hours after the last dose of rivaroxaban.
Subject recruitment occurred at investigative site in the US between March 2013 through April 2014
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| ID | Title | Description |
|---|---|---|
| FG000 | Module 2 Placebo | Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion |
| FG001 | Module 2 (210 mg) | 210 mg andexanet IV bolus administered over 7 minutes (~30 mg/min) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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This study has four modules with a total of 21 cohorts, each module was reported and submitted separately.
Module 1, NCT01758432 (54 subjects with 7 cohorts including placebo); Module 2, NCT03578146 (48 subjects with 6 cohorts including placebo); Module 3, NCT03551730 (27 subjects with 4 cohorts including placebo); Module 4, NCT03551743 (28 subjects with 4 cohorts including placebo)
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|
| Module 2 Placebo | Experimental | Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous fusion. |
|
|
| Placebo/Rivaroxaban | Combination Product |
|
| Placebo | Drug |
|
| Efficacy: Percent Change From Baseline in Unbound Rivaroaxaban Plasma Concentration at 2 Mins Following Andexanet/Placebo Administration | Unbound rivaroxaban concentrations was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Unbound plasma concentrations for rivaroxaban were determined by a rapid equilibrium dialysis method followed by Liquid Chromatography-Mass Spectometry assay. | Baseline to 2 minutes following the end of andexanet/placebo administration |
| Andexanet Maximum Observed Plasma Concentration (Cmax) | Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. | Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose. |
| Andexanet Area Under the Drug Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf ) | Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. AUC0-inf was calculated using a non-compartmental approach | Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose. |
| Andexanet Time of Maximum Observed Plasma Concentration (Tmax) | Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Tmax was taken directly from the raw data. | Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose. |
| Andexanet Apparent Terminal Elimination Half-life (t1/2) | Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. t1/2 was determined by linear regression of the log concentration on the terminal portion of the plasma concentration-time curve. | Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose. |
| Andexanet Total Systemic Clearance (CL) | Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. CL was calculated using a non-compartmental approach, calculated as Dose/AUC0-inf | Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose. |
| Andexanet Total Volume of Distribution (Vss) | Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Vss was calculated using a non-compartmental approach. | Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose. |
| FG002 | Module 2 (420 mg) | 420 mg andexanet IV bolus administered over 14 minutes (~30 mg/min) |
| FG003 | Module 2 (600 mg) | 600 mg andexanet IV bolus administered over 20 minutes (~30 mg/min) |
| FG004 | Module 2 (720 mg Bolus + 240 mg Infusion) | 720 mg IV bolus administered over 24 minutes [~30 mg/min] followed by 240 mg continuous IV infusion [4 mg/min over 60 min)](streamdown:incomplete-link) |
| FG005 | Module 2 (800 mg Bolus + 960 mg Infusion) | 800 mg IV bolus administered over 26.7 minutes [~30 mg/min] followed by 960 mg continuous IV infusion [8 mg/min over 120 min] |
| COMPLETED |
|
| NOT COMPLETED |
|
|
48 subjects were enrolled in this study. Three subjects received rivaroxaban but were discontinued prior to receiving andexanet/placebo due to problems with the infusion pumps observed in prior subjects in the cohort and these subjects were replaced.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Module 2 Placebo | Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion |
| BG001 | Module 2 (210 mg) | 210 mg andexanet IV bolus administered over 7 minutes (~30 mg/min) |
| BG002 | Module 2 (420 mg) | 420 mg andexanet IV bolus administered over 14 minutes (~30 mg/min) |
| BG003 | Module 2 (600 mg) | 600 mg andexanet IV bolus administered over 20 minutes (~30 mg/min) |
| BG004 | Module 2 (720 mg Bolus + 240 mg Infusion) | 720 mg IV bolus administered over 24 minutes [~30 mg/min] followed by 240 mg continuous IV infusion [4 mg/min over 60 min)](streamdown:incomplete-link) |
| BG005 | Module 2 (800 mg Bolus + 960 mg Infusion) | 800 mg IV bolus administered over 26.7 minutes [~30 mg/min] followed by 960 mg continuous IV infusion [8 mg/min over 120 min] |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy: Percent Change From Baseline in Anti-fXa Activity at 2 Mins Following Andexanet/Placebo Administration | Anti-fXa activity was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Anti-fXa activity was measured using a commercial kit (Coamatic Heparin-82 33 9363, DiaPharma) | 45 subjects who received andexanet or placebo were included in the pharmacodynamics (PD) analysis | Posted | Mean | Standard Deviation | Percent change in anti-fXa activity | Baseline to 2 minutes following the end of andexanet/placebo administration |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Efficacy: Percent Change From Baseline in Thrombin Generation at 2 Mins Following Andexanet/Placebo Administration | Thrombin generation was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Thrombin generation was measured using a TF-initiated thrombin generation assay. | 45 subjects who received andexanet or placebo were included in the PD analysis | Posted | Mean | Standard Deviation | Percent change in thrombin generation | Baseline to 2 minutes following the end of andexanet/placebo administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Efficacy: Percent Change From Baseline in Unbound Rivaroaxaban Plasma Concentration at 2 Mins Following Andexanet/Placebo Administration | Unbound rivaroxaban concentrations was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Unbound plasma concentrations for rivaroxaban were determined by a rapid equilibrium dialysis method followed by Liquid Chromatography-Mass Spectometry assay. | 45 subjects who received rivaroxaban were included in the rivaroxaban pharmacokinetics (PK) analysis | Posted | Mean | Standard Deviation | Percent change in unbound apixaban conc. | Baseline to 2 minutes following the end of andexanet/placebo administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Andexanet Maximum Observed Plasma Concentration (Cmax) | Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. | 30 subjects who received andexanet were included in the andexanet PK analysis | Posted | Mean | Standard Deviation | ng/mL | Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Andexanet Area Under the Drug Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf ) | Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. AUC0-inf was calculated using a non-compartmental approach | 30 subjects who received andexanet were included in the andexanet PK analysis | Posted | Mean | Standard Deviation | ng*hr/mL | Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Andexanet Time of Maximum Observed Plasma Concentration (Tmax) | Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Tmax was taken directly from the raw data. | 30 subjects who received andexanet were included in the andexanet PK analysis | Posted | Median | Full Range | hr | Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Andexanet Apparent Terminal Elimination Half-life (t1/2) | Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. t1/2 was determined by linear regression of the log concentration on the terminal portion of the plasma concentration-time curve. | 30 subjects who received andexanet were included in the andexanet PK analysis | Posted | Mean | Standard Deviation | hr | Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Andexanet Total Systemic Clearance (CL) | Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. CL was calculated using a non-compartmental approach, calculated as Dose/AUC0-inf | 30 subjects who received andexanet were included in the andexanet PK analysis | Posted | Mean | Standard Deviation | L/hr | Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Andexanet Total Volume of Distribution (Vss) | Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Vss was calculated using a non-compartmental approach. | 30 subjects who received andexanet were included in the andexanet PK analysis | Posted | Mean | Standard Deviation | L | Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose. |
|
~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Module 2 Placebo | Placebo administered intravenously (IV) as a bolus or a bolus followed by continuous infusion | 0 | 15 | 12 | 15 | ||
| EG001 | Module 2 (210 mg) | 210 mg andexanet IV bolus administered over 7 minutes (~30 mg/min) | 0 | 6 | 4 | 6 | ||
| EG002 | Module 2 (420 mg) | 420 mg andexanet IV bolus administered over 14 minutes (~30 mg/min) | 0 | 6 | 3 | 6 | ||
| EG003 | Module 2 (600 mg) | 600 mg andexanet IV bolus administered over 20 minutes (~30 mg/min) | 0 | 6 | 5 | 6 | ||
| EG004 | Module 2 (720 mg Bolus + 240 mg Infusion) | 720 mg IV bolus administered over 24 minutes [~30 mg/min] followed by 240 mg continuous IV infusion [4 mg/min over 60 min)](streamdown:incomplete-link) | 0 | 6 | 5 | 6 | ||
| EG005 | Module 2 (800 mg Bolus + 960 mg Infusion) | 800 mg IV bolus administered over 26.7 minutes [~30 mg/min] followed by 960 mg continuous IV infusion [8 mg/min over 120 min] | 0 | 6 | 5 | 6 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Catheter site haemorrhage | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Catheter site phlebitis | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Tenderness | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Vessel puncture site haematoma | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Vessel puncture site pain | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Vessel puncture site reaction | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Vessel puncture site swelling | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Infusion-related reaction | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| Post procedural swelling | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Tunnel vision | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
Conducted in healthy volunteers at Clinical Research Organization.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Development | Portola Pharmaceuticals, Inc. | 650-246-7000 |
| ID | Term |
|---|---|
| C580915 | PRT064445 |
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Least Squares Means (Difference) |
| -153.99 |
| 2-Sided |
| Superiority |
| ANCOVA | <0.0001 | Least Squares Means (Difference) | -189.57 | 2-Sided | Superiority |
| ANCOVA | <0.0001 | Least Squares Means (Difference) | -239.3 | 2-Sided | Superiority |
| ANCOVA | <0.0001 | Least Squares Means (Difference) | -231.12 | 2-Sided | Superiority |
| OG004 | Module 2 (720 mg Bolus + 240 mg Infusion) | 720 mg IV bolus administered over 24 minutes [~30 mg/min] followed by 240 mg continuous IV infusion [4 mg/min over 60 min)](streamdown:incomplete-link) |
| OG005 | Module 2 (800 mg Bolus + 960 mg Infusion) | 800 mg IV bolus administered over 26.7 minutes [~30 mg/min] followed by 960 mg continuous IV infusion [8 mg/min over 120 min] |
|
|
|
600 mg andexanet IV bolus administered over 20 minutes (~30 mg/min) |
| OG004 | Module 2 (720 mg Bolus + 240 mg Infusion) | 720 mg IV bolus administered over 24 minutes [~30 mg/min] followed by 240 mg continuous IV infusion [4 mg/min over 60 min)](streamdown:incomplete-link) |
| OG005 | Module 2 (800 mg Bolus + 960 mg Infusion) | 800 mg IV bolus administered over 26.7 minutes [~30 mg/min] followed by 960 mg continuous IV infusion [8 mg/min over 120 min] |
|
|
|
| OG004 | Module 2 (720 mg Bolus + 240 mg Infusion) | 720 mg IV bolus administered over 24 minutes [~30 mg/min] followed by 240 mg continuous IV infusion [4 mg/min over 60 min)](streamdown:incomplete-link) |
| OG005 | Module 2 (800 mg Bolus + 960 mg Infusion) | 800 mg IV bolus administered over 26.7 minutes [~30 mg/min] followed by 960 mg continuous IV infusion [8 mg/min over 120 min] |
|
|
| OG004 | Module 2 (720 mg Bolus + 240 mg Infusion) | 720 mg IV bolus administered over 24 minutes [~30 mg/min] followed by 240 mg continuous IV infusion [4 mg/min over 60 min)](streamdown:incomplete-link) |
| OG005 | Module 2 (800 mg Bolus + 960 mg Infusion) | 800 mg IV bolus administered over 26.7 minutes [~30 mg/min] followed by 960 mg continuous IV infusion [8 mg/min over 120 min] |
|
|
| OG004 | Module 2 (720 mg Bolus + 240 mg Infusion) | 720 mg IV bolus administered over 24 minutes [~30 mg/min] followed by 240 mg continuous IV infusion [4 mg/min over 60 min)](streamdown:incomplete-link) |
| OG005 | Module 2 (800 mg Bolus + 960 mg Infusion) | 800 mg IV bolus administered over 26.7 minutes [~30 mg/min] followed by 960 mg continuous IV infusion [8 mg/min over 120 min] |
|
|
600 mg andexanet IV bolus administered over 20 minutes (~30 mg/min)
| OG004 | Module 2 (720 mg Bolus + 240 mg Infusion) | 720 mg IV bolus administered over 24 minutes [~30 mg/min] followed by 240 mg continuous IV infusion [4 mg/min over 60 min)](streamdown:incomplete-link) |
| OG005 | Module 2 (800 mg Bolus + 960 mg Infusion) | 800 mg IV bolus administered over 26.7 minutes [~30 mg/min] followed by 960 mg continuous IV infusion [8 mg/min over 120 min] |
|
|
| OG004 | Module 2 (720 mg Bolus + 240 mg Infusion) | 720 mg IV bolus administered over 24 minutes [~30 mg/min] followed by 240 mg continuous IV infusion [4 mg/min over 60 min)](streamdown:incomplete-link) |
| OG005 | Module 2 (800 mg Bolus + 960 mg Infusion) | 800 mg IV bolus administered over 26.7 minutes [~30 mg/min] followed by 960 mg continuous IV infusion [8 mg/min over 120 min] |
|
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| OG004 | Module 2 (720 mg Bolus + 240 mg Infusion) | 720 mg IV bolus administered over 24 minutes [~30 mg/min] followed by 240 mg continuous IV infusion [4 mg/min over 60 min)](streamdown:incomplete-link) |
| OG005 | Module 2 (800 mg Bolus + 960 mg Infusion) | 800 mg IV bolus administered over 26.7 minutes [~30 mg/min] followed by 960 mg continuous IV infusion [8 mg/min over 120 min] |
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