Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 1 of 4)
NCT ID: NCT01758432
Last Updated: 2023-08-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
54 participants
INTERVENTIONAL
2012-12-31
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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)
TREATMENT
QUADRUPLE
Study Groups
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Module 1 (90 mg bolus)
90 mg PRT064445 given as a single IV
PRT064445/Apixaban
Placebo/Apixaban
Module 1 (210 mg bolus)
210 mg PRT064445 given as a single IV bolus
PRT064445/Apixaban
Placebo/Apixaban
Module 1 (420 mg bolus)
420 mg PRT064445 given as a single IV bolus
PRT064445/Apixaban
Placebo/Apixaban
Module 1 (420 mg bolus + 180 mg infusion) 4 mg/min
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)
PRT064445/Apixaban
Placebo/Apixaban
Module 1 (420 mg bolus + 180 mg bolus) 30mg/min
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
PRT064445/Apixaban
Placebo/Apixaban
Module 1 (420 mg bolus + 480 mg infusion) 4mg/min
900 mg PRT064445 given as follows: 420 mg IV, followed by a continuous infusion of 480 mg (4 mg/min over 120 minutes
PRT064445/Apixaban
Placebo/Apixaban
Module 1 Placebo
Placebo administered intravenously (IV) as a bolus, two bolus doses or a bolus followed by continuous infusion.
Placebo
Interventions
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PRT064445/Apixaban
Placebo/Apixaban
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History (including family history) of or risk factors for a hypercoagulable or thrombotic condition
* Absolute/relative contraindication to anticoagulation or treatment with specific anticoagulants
* History of major surgery, severe trauma or bone fracture within 3 months prior to dosing; or planned surgery within 1 month after dosing.
18 Years
45 Years
ALL
Yes
Sponsors
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Portola Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Tempe, Arizona, United States
Countries
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References
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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.
Other Identifiers
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12-502 Module 1
Identifier Type: -
Identifier Source: org_study_id
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