At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 27 enrolled
Drug / intervention
PRT064445/Enoxaparin +2 morecombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Vehicle-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Intravenously Administered PRT064445 After Dosing to Steady State With One of Four Direct/Indirect Factor Xa (fXa) Inhibitors in Healthy Volunteers.
In Brief
A Phase 2 clinical trial evaluating PRT064445/Enoxaparin, Placebo/Enoxaparin, and 1 other intervention for Healthy Volunteers. Completed, enrolled 27 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2012
Primary CompletionSep 2015
First PostedJun 2018
TodayJul 2026
First PostedJun 11, 2018
Enrollment StartDec 1, 2012
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 8.1 years ago
Interventions
PRT064445/Enoxaparincombination
Placebo/Enoxaparincombination
Placebodrug