Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 4 of 4)
NCT03551743 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2023-02-21
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/Edoxaban
- COMBINATION_PRODUCT
-
Placebo/Edoxaban
- 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
More Related Trials
-
Study of PER977 Administered to Subjects With Steady State Edoxaban Dosing and Re-anticoagulation With Edoxaban
NCT02207257 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Pharmacodynamic Equivalence of Enoxaparin Rovi to Clexane®, in Healthy Volunteers
NCT03363477 ·Status: COMPLETED ·Phase: PHASE1
-
Factor Xa Inhibitor, PRT054021, Against Enoxaparin for the Prevention of Venous Thromboembolic Events (EXPERT)
NCT00375609 ·Status: COMPLETED ·Phase: PHASE2
-
A Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian Subjects
NCT03310021 ·Status: COMPLETED ·Phase: PHASE2
-
Below Knee DVT Study
NCT03805672 ·Status: TERMINATED ·Phase: PHASE4
-
A Two-part Study in Edoxaban-treated Healthy Subjects to Establish a Punch Biopsy Bleeding Model and to Evaluate the Effect of a 4-factor Prothrombin Complex Concentrate on Anticoagulation
NCT02047565 ·Status: COMPLETED ·Phase: PHASE1
-
Fixed Versus Variable Dosing of 4-factor Prothrombin Complex Concentrate for Emergent Warfarin Reversal
NCT03064035 ·Status: COMPLETED ·Phase: PHASE4
-
A Randomized, Open-Label, Parallel-Group, Multi-Center Study for the Evaluation of Efficacy and Safety of Edoxaban Monotherapy Versus Low Molecular Weight (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis
NCT01662908 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Male Subjects
NCT02949206 ·Status: COMPLETED ·Phase: PHASE1
-
Prevention of Thromboembolic Events in Total Knee Replacement Patients
NCT03393481 ·Status: WITHDRAWN ·Phase: PHASE2
-
Influence of Edoxaban on Coagulability and Thrombin Generation: An in Vitro Study Focusing on Thrombelastography
NCT02448901 ·Status: UNKNOWN
-
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
-
Study to Test the Accuracy of a Prototype Handheld PT/INR Device
NCT01349712 ·Status: UNKNOWN
-
A Study of JNJ-70033093 (BMS-986177) Versus Subcutaneous Enoxaparin in Participants Undergoing Elective Total Knee Replacement Surgery
NCT03891524 ·Status: COMPLETED ·Phase: PHASE2
-
Thromboprophylaxis With Rivaroxaban In Patients With Malignancy and Central Venous Lines
NCT03506815 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Prothromplex Total (Prothrombin Complex Concentrate) in Oral Anticoagulant Reversal
NCT01159210 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Efficacy of Edoxaban and Rivaroxaban to Cerebral Venous Thrombosis in Chinese Patients
NCT06947707 ·Status: RECRUITING
-
A Healthy Volunteer PK/PD, Safety and Tolerability Study of Andexanet After Betrixaban Dosing
NCT03330457 ·Status: TERMINATED ·Phase: PHASE2
-
Rivaroxaban and Vitamin K Antagonists for the Anticoagulation for the Implantation of Vena Cava Filters
NCT04066764 ·Status: RECRUITING ·Phase: PHASE3
-
Edoxaban Treatment Versus Vitamin K Antagonist in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention
NCT02866175 ·Status: COMPLETED ·Phase: PHASE3
-
THromboprophylaxis In Sickle Cell Disease With Central Venous Catheters (THIS)
NCT05033314 ·Status: TERMINATED ·Phase: PHASE3
-
Deep Vein Thrombosis Prophylaxis Adherence: Enoxaparin vs Rivaroxaban
NCT04169269 ·Status: UNKNOWN ·Phase: PHASE4
-
A Study to Assess the Reversal of the Anticoagulant Effects of Milvexian by 4-Factor Prothrombin Complex Concentrate (4F-PCC) (Part 1) and Recombinant Human Factor VIIa (rFVIIa) (Part 2) in Healthy Participants
NCT04543383 ·Status: COMPLETED ·Phase: PHASE1
-
Identification and Treatment of Clinically Silent Catheter-Related Deep Vein Thrombosis in Children With Cancer
NCT00633061 ·Status: TERMINATED ·Phase: PHASE2
-
A Healthy Volunteer Study to Evaluate for a Single Dose of 4 Different Tablets of DPOC-4088 the Absorption and Elimination From the Body and the Potential Effect on Blood Clotting
NCT01347203 ·Status: COMPLETED ·Phase: PHASE1