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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, and pharmacodynamics of intravenously administered PRT064445 after dosing to steady state with one of four direct/indirect fXa inhibitors in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Module 1 (90 mg bolus) | Experimental | 90 mg PRT064445 given as a single IV |
|
| Module 1 (210 mg bolus) | Experimental | 210 mg PRT064445 given as a single IV bolus |
|
| Module 1 (420 mg bolus) | Experimental | 420 mg PRT064445 given as a single IV bolus |
|
| Module 1 (420 mg bolus + 180 mg infusion) 4 mg/min | Experimental | 600 mg PRT064445 given as follows: 420 mg IV over ~14 minutes (~30 mg/min), followed by a continuous infusion of 180 mg (4 mg/min over 45 minutes) |
|
| Module 1 (420 mg bolus + 180 mg bolus) 30mg/min | Experimental | 600 mg PRT064445 given as follows: up to 420 mg IV over ~14 minutes (~30 mg/min), followed by a second bolus of 180 mg IV over ~6 minutes (~30 mg/min), 45 minutes after completion of the bolus |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRT064445/Apixaban | 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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tempe | Arizona | 85283 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29296829 | Derived | Siegal D, Lu G, Leeds JM, Karbarz M, Castillo J, Mathur V, Hutchaleelaha A, Sinha U, Kitt M, McClure M, Hollenbach SJ, Curnutte JT, Conley PB, Crowther M. Safety, pharmacokinetics, and reversal of apixaban anticoagulation with andexanet alfa. Blood Adv. 2017 Sep 22;1(21):1827-1838. doi: 10.1182/bloodadvances.2017007112. eCollection 2017 Sep 26. |
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Apixaban was administered orally at 5 mg twice daily for 6 days to steady-state in an open label fashion. Subjects were then randomized to receive study treatment (andexanet:placebo, 6:3) 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 apixaban.
Subject recruitment occurred at investigative site in the US between November 2012 through October 2013
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| ID | Title | Description |
|---|---|---|
| FG000 | Module 1 Placebo | Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion. |
| FG001 | Module 1 ( 90 mg) | 90 mg andexanet IV bolus administered over 3 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 7cohorts 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 1 (420 mg bolus + 480 mg infusion) 4mg/min | Experimental | 900 mg PRT064445 given as follows: 420 mg IV, followed by a continuous infusion of 480 mg (4 mg/min over 120 minutes |
|
| Module 1 Placebo | Placebo Comparator | Placebo administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion. |
|
|
| Placebo/Apixaban | Combination Product |
|
| Placebo | Drug |
|
| Efficacy: Percent Change From Baseline in Unbound Apixaban Plasma Concentration at 2 Mins Following Andexanet/Placebo Administration | Unbound apixaban concentrations was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Unbound plasma concentrations for apixaban 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. Cmax 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 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 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. |
| 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 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 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 electro chemiluminescent 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. |
| FG002 | Module 1 (210 mg) | 210 mg andexanet IV bolus administered over 10 minutes (~30 mg/min) |
| FG003 | Module 1 (420 mg) | 420 mg andexanet IV bolus administered over 15 minutes (~30 mg/min) |
| FG004 | Module 1 (420 mg Bolus + 180 mg Infusion) | 420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) [total 600 mg] |
| FG005 | Module 1 (420 mg Bolus + 180 mg Bolus) | 420 mg andexanet/placebo IV bolus administered over ~14 minutes (~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over~ 6 minutes (~30 mg/min) [total 600 mg] |
| FG006 | Module 1 (420 mg Bolus + 480 mg Infusion) | 420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) [total 900 mg] |
| COMPLETED |
|
| NOT COMPLETED |
|
54 subjects were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Module 1 Placebo | Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion. |
| BG001 | Module 1 ( 90 mg) | 90 mg andexanet IV bolus administered over 3 minutes (~30 mg/min) |
| BG002 | Module 1 (210 mg) | 210 mg andexanet IV bolus administered over 10 minutes (~30 mg/min) |
| BG003 | Module 1 (420 mg) | 420 mg andexanet IV bolus administered over 15 minutes (~30 mg/min) |
| BG004 | Module 1 (420 mg Bolus + 180 mg Infusion) | 420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) [total 600 mg] |
| BG005 | Module 1 (420 mg Bolus + 180 mg Bolus) | 420 mg andexanet/placebo IV bolus administered over ~14 minutes (~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over~ 6 minutes (~30 mg/min) [total 600 mg] |
| BG006 | Module 1 (420 mg Bolus + 480 mg Infusion) | 420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) [total 900 mg] |
| BG007 | 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 | 54 subjects were enrolled in this study. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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) | 54 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 |
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| 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 |
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| Secondary | Efficacy: Percent Change From Baseline in Unbound Apixaban Plasma Concentration at 2 Mins Following Andexanet/Placebo Administration | Unbound apixaban concentrations was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Unbound plasma concentrations for apixaban were determined by a rapid equilibrium dialysis method followed by Liquid Chromatography-Mass Spectometry assay. | 54 subjects who received apixaban were included in the apixaban pharmacokinetics (PK) analysis | Posted | Mean | Standard Deviation | % change in unbound apixaban concentrat. | Baseline to 2 minutes following the end of andexanet/placebo administration |
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| 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. Cmax was taken directly from the raw data. | 36 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. |
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| 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. | 36 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. |
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| 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. | 36 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. |
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| 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 | 36 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. |
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| 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 | 36 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. |
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| 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 electro chemiluminescent assay. t1/2 was determined by linear regression of the log concentration on the terminal portion of the plasma concentration-time curve. | 36 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. |
|
~7 weeks
Only subjects who received at least one dose of study drug were included in the safety analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Module 1 Placebo | Placebo was administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion. | 0 | 18 | 14 | 18 | ||
| EG001 | Module 1 ( 90 mg) | 90 mg andexanet IV bolus administered over 3 minutes (~30 mg/min) | 0 | 6 | 3 | 6 | ||
| EG002 | Module 1 (210 mg) | 210 mg andexanet IV bolus administered over 10 minutes (~30 mg/min) 420 mg andexanet IV bolus administered over 15 minutes (~30 mg/min) | 0 | 6 | 3 | 6 | ||
| EG003 | Module 1 (420 mg) | 420 mg andexanet IV bolus administered over 15 minutes (~30 mg/min) | 0 | 6 | 5 | 6 | ||
| EG004 | Module 1 (420 mg Bolus + 180 mg Infusion) | 420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) [total 600 mg] | 0 | 6 | 4 | 6 | ||
| EG005 | Module 1 (420 mg Bolus + 180 mg Bolus) | 420 mg andexanet/placebo IV bolus administered over ~14 minutes (~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over~ 6 minutes (~30 mg/min) [total 600 mg] | 0 | 6 | 2 | 6 | ||
| EG006 | Module 1 (420 mg Bolus + 480 mg Infusion) | 420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) [total 900 mg] | 0 | 6 | 3 | 6 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ocular hyperaemmia | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Chills | 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 |
| |
| Vessel puncture site haematoma | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Vessel puncture site pain | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Vessel puncture site paraesthesia | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Vessel puncture site swelling | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Post procedural swelling | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Heat rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pruritus generalized | 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 |
| C522181 | apixaban |
Not provided
Not provided
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| Male |
|
| Least Squares Means (Difference) |
| -130.5 |
| 2-Sided |
| 95 |
| Superiority |
| ANCOVA | <0.0001 | Least Squares Means (Difference) | -129.86 | 2-Sided | 95 | Superiority |
| ANCOVA | <0.0001 | Least Squares Means (Difference) | -165.91 | 2-Sided | 95 | Superiority |
| ANCOVA | <0.0001 | Least Squares Means (Difference) | -167.94 | 2-Sided | 95 | Superiority |
| ANCOVA | <0.0001 | Least Squares Means (Difference) | -135.91 | 2-Sided | 95 | Superiority |
| OG004 | Module 1 (420 mg Bolus + 180 mg Infusion) | 420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) [total 600 mg] |
| OG005 | Module 1 (420 mg Bolus + 180 mg Bolus) | 420 mg andexanet/placebo IV bolus administered over ~14 minutes (~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over~ 6 minutes (~30 mg/min) [total 600 mg] |
| OG006 | Module 1 (420 mg Bolus + 480 mg Infusion) | 420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) [total 900 mg] |
|
|
|
420 mg andexanet IV bolus administered over 15 minutes (~30 mg/min) |
| OG004 | Module 1 (420 mg Bolus + 180 mg Infusion) | 420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) [total 600 mg] |
| OG005 | Module 1 (420 mg Bolus + 180 mg Bolus) | 420 mg andexanet/placebo IV bolus administered over ~14 minutes (~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over~ 6 minutes (~30 mg/min) [total 600 mg] |
| OG006 | Module 1 (420 mg Bolus + 480 mg Infusion) | 420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) [total 900 mg] |
|
|
|
| OG004 | Module 1 (420 mg Bolus + 180 mg Infusion) | 420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) [total 600 mg] |
| OG005 | Module 1 (420 mg Bolus + 180 mg Bolus) | 420 mg andexanet/placebo IV bolus administered over ~14 minutes (~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over~ 6 minutes (~30 mg/min) [total 600 mg] |
| OG006 | Module 1 (420 mg Bolus + 480 mg Infusion) | 420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) [total 900 mg] |
|
|
| OG004 | Module 1 (420 mg Bolus + 180 mg Infusion) | 420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) [total 600 mg] |
| OG005 | Module 1 (420 mg Bolus + 180 mg Bolus) | 420 mg andexanet/placebo IV bolus administered over ~14 minutes (~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over~ 6 minutes (~30 mg/min) [total 600 mg] |
| OG006 | Module 1 (420 mg Bolus + 480 mg Infusion) | 420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) [total 900 mg] |
|
|
| OG004 | Module 1 (420 mg Bolus + 180 mg Infusion) | 420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) [total 600 mg] |
| OG005 | Module 1 (420 mg Bolus + 180 mg Bolus) | 420 mg andexanet/placebo IV bolus administered over ~14 minutes (~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over~ 6 minutes (~30 mg/min) [total 600 mg] |
| OG006 | Module 1 (420 mg Bolus + 480 mg Infusion) | 420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) [total 900 mg] |
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420 mg andexanet IV bolus administered over 15 minutes (~30 mg/min)
| OG004 | Module 1 (420 mg Bolus + 180 mg Infusion) | 420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) [total 600 mg] |
| OG005 | Module 1 (420 mg Bolus + 180 mg Bolus) | 420 mg andexanet/placebo IV bolus administered over ~14 minutes (~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over~ 6 minutes (~30 mg/min) [total 600 mg] |
| OG006 | Module 1 (420 mg Bolus + 480 mg Infusion) | 420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) [total 900 mg] |
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| OG004 | Module 1 (420 mg Bolus + 180 mg Infusion) | 420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) [total 600 mg] |
| OG005 | Module 1 (420 mg Bolus + 180 mg Bolus) | 420 mg andexanet/placebo IV bolus administered over ~14 minutes (~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over~ 6 minutes (~30 mg/min) [total 600 mg] |
| OG006 | Module 1 (420 mg Bolus + 480 mg Infusion) | 420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) [total 900 mg] |
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420 mg andexanet IV bolus administered over 15 minutes (~30 mg/min)
| OG004 | Module 1 (420 mg Bolus + 180 mg Infusion) | 420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 180 mg continuous IV infusion (4 mg/min over 45 minutes) [total 600 mg] |
| OG005 | Module 1 (420 mg Bolus + 180 mg Bolus) | 420 mg andexanet/placebo IV bolus administered over ~14 minutes (~30 mg/min) followed after 45 minutes by a second bolus of 180 mg over~ 6 minutes (~30 mg/min) [total 600 mg] |
| OG006 | Module 1 (420 mg Bolus + 480 mg Infusion) | 420 mg andexanet IV bolus administered over ~14 minutes (~30 mg/min) followed immediately by a 480 mg continuous IV infusion (4 mg/min over 2 hours) [total 900 mg] |
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