NCT01656330

Brief Summary

The purpose of this study is to assess the use of 2 different Prothrombin Complex Concentrates (PCCs) on their ability to reverse (normalize) the pharmacodynamic effects of rivaroxaban in healthy adult volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jul 2012

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2012

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2012

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

1 month

First QC Date

July 31, 2012

Last Update Submit

January 23, 2017

Conditions

Healthy

Keywords

HealthyRivaroxabanJNJ-39039039BAY59-7939Prothrombin Complex Concentrate (PCC)

Outcome Measures

Primary Outcomes (1)

  • Measurement of pharmacodynamic (PD) variables: prothrombin time (PT), International Normalized Ratio (INR), activated partial thromboplastin time (aPTT), thrombin generation assay (TGA) and anti-Factor Xa (anti-FXa)

    Pharamacodymic (PD) variables (ie, PT, INR, aPTT, TGA, and anti-FXa) are blood coagulation (or clotting) tests. These blood clotting tests will be performed to assess the effects of Prothrombin Complex Concentrates (PCCs) (Profilnine SD or Beriplex P/N) on the pharmacodynamics of rivaroxaban.

    Days 1-6

Secondary Outcomes (6)

  • Rivaroxaban plasma concentrations

    Days 1-6

  • The number of healthy volunteers reporting adverse events

    Days 1-6

  • Changes from baseline in clinical laboratory tests performed

    Day 1; Day 6

  • Change from baseline in electrocardiogram (ECG) findings

    Day 1; Day 6

  • Change from baseline physical examination findings

    Day 1; Day 6

  • +1 more secondary outcomes

Study Arms (3)

Rivaroxaban + Profilnine SD

EXPERIMENTAL

Rivaroxaban 20 mg twice a day on Days 1-4 followed by rivaroxaban 20 mg once a day on Day 5 administered 4 hours before a single bolus dose of Profilnine SD 50 IU/kg.

Drug: Rivaroxaban 20 mg twice dailyDrug: Rivaroxaban 20 mg once dailyDrug: Profilnine SD

Rivaroxaban + Beriplex P/N

EXPERIMENTAL

Rivaroxaban 20 mg twice a day on Days 1-4 followed by rivaroxaban 20 mg once a day on Day 5 administered 4 hours before a single bolus dose of Beriplex 50 IU/kg.

Drug: Rivaroxaban 20 mg twice dailyDrug: Rivaroxaban 20 mg once dailyDrug: Beriplex P/N

Rivaroxaban + Saline

EXPERIMENTAL

Rivaroxaban 20 mg twice a day on Days 1-4 followed by rivaroxaban 20 mg once a day on Day 5 administered 4 hours before a single 100cc bolus of saline.

Drug: Rivaroxaban 20 mg twice dailyDrug: Rivaroxaban 20 mg once dailyOther: Saline

Interventions

Rivaroxaban 20 mg twice dailyDRUG

One rivaroxaban 20 mg tablet administered twice a day (b.i.d.) for 4 days (Days 1-4). Interpretation by CTRL: Concentration type = Exact; Number = 20; unit=mg; route: oral use for 4 days.

Rivaroxaban + Beriplex P/NRivaroxaban + Profilnine SDRivaroxaban + Saline
Rivaroxaban 20 mg once dailyDRUG

One rivaroxaban 20 mg tablet administered once daily on Day 5. Interpretation by CTRL: Concentration type = Exact; Number = 20; unit=mg; route: oral use for 1 day.

Rivaroxaban + Beriplex P/NRivaroxaban + Profilnine SDRivaroxaban + Saline
Profilnine SDDRUG

Single bolus dose of Profilnine SD 50 IU/kg administered by intravenous (IV) injection on Day 5. Interpretation by CTRL: Concentration type = Exact; Number = 50; unit=IU/kg; route: intraveous use.

Rivaroxaban + Profilnine SD
Beriplex P/NDRUG

Single bolus dose of Beriplex P/N 50 IU/kg administered by intravenous (IV) injection on Day 5 Interpretation by CTRL: Concentration type = Exact ; Number = 50; unit=IU/kg; route : intravenous use

Rivaroxaban + Beriplex P/N
SalineOTHER

Single 100 cc bolus of saline administered by intravenous (IV) injection on Day 5. Interpretation by CTRL: Concentration type = Exact ; Number = 100; unit=cc; route : intravenous use use.

Rivaroxaban + Saline

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Have coagulation test results of PT, INR and aPTT that are within normal limits
  • Have a Body Mass Index (BMI; weight \[kg\]/height2 \[m\]2) between 18 and 30 kg/m2 (inclusive), and body weight between 50 and 100 kg
  • Have blood pressure (after the volunteer is supine \[lying down with the face up\] for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and between 50 and 90 mmHg diastolic
  • Non-smoker

You may not qualify if:

  • History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic (blood) disease, thrombosis, coagulation (blood clotting) disorders, lipid abnormalities, significant pulmonary (lung) disease, diabetes mellitus, renal (kidney) or hepatic (liver) insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the volunteer or that could interfere with the interpretation of the study results
  • History of serious bleeding in the past, including gastrointestinal bleeding requiring hospitalization, intracranial (in the brain) bleeding of any type, or uncontrollable postoperative bleeding
  • History of intracranial tumor or aneurysm or known abdominal aneurysm
  • Known allergy to the study drug or any of the excipients of the formulation
  • Known allergy to heparin or history of heparin-induced thrombocytopenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Merksem, Belgium

Location

MeSH Terms

Conditions

Hemophilia B

Interventions

RivaroxabanProfilnine SDfactor IX, factor VII, factor X, prothrombin drug combinationSodium Chloride

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-Linked

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Janssen Research & Development, L.L.C Clinical Trial

    Janssen Research & Development, L.L.C

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2012

First Posted

August 3, 2012

Study Start

July 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

January 24, 2017

Record last verified: 2017-01

Locations

BE(1)