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Clinical trial

A Randomized, Double-Blind, Vehicle-Controlled Multiple Dose 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

ID
Name
12-502 Module 2
Description
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.
Trial arms
Trial start
2012-12-01
Estimated PCD
2015-09-01
Trial end
2015-09-01
Status
Completed
Phase
Early phase I
Treatment
PRT064445/Rivaroxaban
Arms:
Module 2 (210 mg), Module 2 (420 mg), Module 2 (600 mg), Module 2 (720 mg bolus + 240 mg infusion), Module 2 (800 mg bolus + 960 mg infusion)
Other names:
Andexanet
Placebo/Rivaroxaban
Arms:
Module 2 (210 mg), Module 2 (420 mg), Module 2 (600 mg), Module 2 (720 mg bolus + 240 mg infusion), Module 2 (800 mg bolus + 960 mg infusion)
Placebo
Arms:
Module 2 Placebo
Size
48
Primary endpoint
Efficacy: Percent Change From Baseline in Anti-fXa Activity at 2 Mins Following Andexanet/Placebo Administration
Baseline to 2 minutes following the end of andexanet/placebo administration
Eligibility criteria
Inclusion Criteria: * Healthy men or women between the ages of 18 and 45 years old Exclusion Criteria: * History (including family history) or symptoms of, or risk factors for bleeding * 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study has four modules with a total of 21 cohorts, each module was reported and submitted separately.\n\nModule 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)', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 48, 'type': 'ACTUAL'}}
Updated at
2023-02-22

1 organization

3 products

1 indication

Organization
Portola Pharmaceuticals
Product
Placebo
Indication
Healthy Control Participants
Product
PRT064445/Rivaroxaban
Product
Placebo/Rivaroxaban