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)
NCT01758432 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2023-08-07
Summary
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.
Conditions
- Healthy Volunteers
Interventions
- COMBINATION_PRODUCT
-
PRT064445/Apixaban
- COMBINATION_PRODUCT
-
Placebo/Apixaban
- DRUG
Sponsors & Collaborators
-
Portola Pharmaceuticals
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-12-31
- Primary Completion
- 2015-09-30
- Completion
- 2015-09-30
Countries
- United States
Study Locations
More Related Trials
-
Fixed Versus Variable Dosing of 4-factor Prothrombin Complex Concentrate for Emergent Warfarin Reversal
NCT03064035 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism
NCT00643201 ·Status: COMPLETED ·Phase: PHASE3
-
Below Knee DVT Study
NCT03805672 ·Status: TERMINATED ·Phase: PHASE4
-
A Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian Subjects
NCT03310021 ·Status: COMPLETED ·Phase: PHASE2
-
A Pilot Trial Comparing Full Dose Rivaroxaban to Prophylactic Dose Rivaroxaban in Patients With Superficial Vein Thrombosis in the Leg
NCT06965998 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
A Open-label, Three-period, Partial-replicate Design Study to Evaluate the Inter- and Intrasubject Variability of the Avatrombopag To-be-marketed Formulation Administered as Single Doses of 40 mg to Healthy Subjects Receiving a Low-fat Meal
NCT01759394 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Test the Accuracy of a Prototype Handheld PT/INR Device
NCT01349712 ·Status: UNKNOWN
-
Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis (Also Known As Superficial Vein Thrombosis)
NCT00443053 ·Status: COMPLETED ·Phase: PHASE3
-
A Study in Older Subjects to Evaluate the Safety and Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Apixaban
NCT02207725 ·Status: COMPLETED ·Phase: PHASE3
-
Treatment for Blood Clots in the Veins of the Legs
NCT00001713 ·Status: COMPLETED ·Phase: PHASE1
-
Prevention of Thromboembolic Events in Total Knee Replacement Patients
NCT03393481 ·Status: WITHDRAWN ·Phase: PHASE2
-
Outpatient Treatment of Low-Risk Venous Thromboembolism With Target Specific Anticoagulant
NCT02079584 ·Status: COMPLETED
-
Real-time Anti-Factor Xa Measurements in Surgical Patients to Examine Enoxaparin Metabolism and Optimize Enoxaparin Dose
NCT02704052 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Factor Xa Inhibitor, PRT054021, Against Enoxaparin for the Prevention of Venous Thromboembolic Events (EXPERT)
NCT00375609 ·Status: COMPLETED ·Phase: PHASE2
-
Clinical Trial Assessing Non-Inferiority of Freeze Dried Plasma to Fresh Frozen Plasma in Reversing Warfarin
NCT04794348 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Healthy Volunteer PK/PD, Safety and Tolerability Study of Andexanet After Betrixaban Dosing
NCT03330457 ·Status: TERMINATED ·Phase: PHASE2
-
Arixtra PE Study- Outpatient Management of Stable Acute Pulmonary Embolism: Once Daily Subcutaneous Fondaparinux
NCT00378027 ·Status: WITHDRAWN
-
Anti-Xa Guided Dosing of Low Molecular Weight Heparin for Prevention of Venous Thromboembolism Following Traumatic Injury: a Multicentre Pilot Randomized Trial
NCT06662253 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2/PHASE3
-
Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With a Venous Thromboembolism
NCT00423683 ·Status: TERMINATED ·Phase: PHASE3
-
Enoxaparin for Preventing the Radical Artery Occlusion After the Transradial Access Hepatic Arterial Infusion Chemotherapy
NCT06293287 ·Status: RECRUITING ·Phase: PHASE2
-
Evaluation of Venous Thromboembolism Prevention in High-Risk Trauma Patients
NCT02412982 ·Status: COMPLETED ·Phase: PHASE4
-
Thromboprophylaxis With Rivaroxaban In Patients With Malignancy and Central Venous Lines
NCT03506815 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety Study of Apixaban for Extended Treatment of Deep Vein Thrombosis or Pulmonary Embolism
NCT00633893 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery
NCT03251482 ·Status: COMPLETED ·Phase: PHASE2
-
Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism)
NCT02064439 ·Status: COMPLETED ·Phase: PHASE3