HealthyPhase 1NCT02561923

A Study to Assess the Independent Effects of 4-Factor Prothrombin Complex Concentrate and Tranexamic Acid on Bleeding/Pharmacodynamics in Healthy Participants

A Phase 1 study testing Rivaroxaban, Tranexamic acid and Kcentra, a 4-factor PCC in people with Healthy, run by Janssen Scientific Affairs, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Rivaroxaban, Tranexamic acid and Kcentra, a 4-factor PCC
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 158 participants
Where: 1 siteUnited States
Study dates: 27 Aug 2015to 17 Jun 2016
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Body mass index (weight kilogram [kg]/height^2 meters [m]^2) between 18 and 30 kg/m2 (inclusive), and body weight between 50 and 100 kg;
Participants must have coagulation test results of prothrombin time (PT) and a partial thromboplastin time (PTT) within normal limits at Screening
Must have normal renal function, as per medical history
If a woman, must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (eg, double-barrier method or male partner sterilization) before entry and throughout the study. (Note: combined hormonal contraception should not be used)
Non-smoker (Note: subjects should not have used nicotine-containing products within 30 days before study drug administration)
If a woman, must have a negative serum Beta-human chorionic gonadotropin (hCG)] pregnancy test at Screening; and a negative serum pregnancy test on Day -1 of the study
If a man, must agree to use adequate contraception method as deemed appropriate by the investigator (eg, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug

Who cannot join

History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease (including history of definite myocardial infarction, cerebrovascular accident, percutaneous transluminal coronary angioplasty or coronary artery bypass graft within 6 months before the Screening visit, or a previous intracranial hemorrhage at any time, known history of lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, seizure disorder, infection, skin disease, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
Participants with any history of thrombosis, inherited or acquired thrombophilia, bleeding diathesis or coagulopathy (including any abnormal bleeding or blood dyscrasias), hematologic disease, clinically significant hemorrhagic disorder, excessive bruising, bleeding from nose or gums or known disorders with increased bleeding risk (eg, acute gastritis, acute peptic ulcer), serious bleeding including gastrointestinal bleeding requiring hospitalization, intracranial bleeding of any type, or uncontrollable postoperative bleeding
Known antithrombin III, Protein C, or Protein S deficiency, Factor V Leiden or prothrombin gene 20210 mutation, anticardiolipin (immunoglobulin G [IgG] and immunoglobulin M [IgM]) or antiphospholipid antibodies, or family history of unexplained thrombotic disorders
History of intracranial tumor or aneurysm or known abdominal aneurysm
Clinically significant abnormal physical examination, vital signs or 12-lead electrocardigram [ECG] at Screening or at admission to the study center on Day -1, as deemed appropriate by the investigator. This would include: resting pulse >100 or <40 beats per min, blood pressure systolic >140 or <90 millimeters per mercuric level [mmHg], and diastolic blood pressure > 90 or < 50 mmHg (pulse and blood pressure measurements should be taken in a supine position, after resting for at least 5 minutes)
Participants for whom surface blood vessels could not be visualized, or who have a history of likelihood of forming keloid scars

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Use of any prescription or nonprescription medication (including antiplatelet, anticoagulants, aspirin, non-steroidal anti-inflammatory drugs, vitamins and herbal supplements), within 7 days before the first dose of the study drug is scheduled
Known allergy to the study drugs or any of the excipients of the formulations
Unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug)

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Overland Park, Kansas

Other trials in United States

About this study

Official title: Randomized, Parallel-Group, 2-Part Study to Assess the Independent Effects of 4-Factor Prothrombin Complex Concentrate and Tranexamic Acid on Bleeding Parameters and Pharmacodynamics After a Punch Biopsy Procedure in Healthy Subjects Treated With Rivaroxaban

The purpose of this study is to assess the independent effects of both a 4-Factor prothrombin complex concentrate (PCC) - (Kcentra) and Tranexamic acid (TXA) on the bleeding parameters (bleeding duration and blood volume) following a punch biopsy, in addition to assessing their effects on the anticoagulant/pharmacodynamic (prothrombin time and endogenous thrombin potential) changes induced by rivaroxaban at steady state, to better understand their potential role in bleeding reversal.

Read the detailed description

This is a 2 part, single center study to be conducted in healthy men and women. Part 1 (open-label) consists of Screening Phase (within 28 days before admission into the study center on Day -1), followed by a 3 day treatment period and a follow-up visit on Day 8. A single oral 20 milligram (mg) dose of rivaroxaban will be administered on Day 1. Pharmacokinetic (PK), pharmacodynamics (PD), and punch biopsy parameters will be assessed. Part 2 (double-blind) consists of Screening Phase (within 28 days before admission into the study center on Day -1), followed by a 8 day treatment period (Day -1 to Day 7) and a follow-up visit on Day 11. Rivaroxaban (20 mg every 12 hrs) will be administered on Days 1 through 3 and single 20 mg dose will be given on the morning of Day 4. A single dose of either 4-factor PCC, TXA or saline (Placebo) will be administered in a randomized, blinded fashion on Day 4. PK, PD, Exploratory Bio-markers and punch biopsy parameters will be assessed. Participants' safety will be monitored throughout the study.

Conditions: Healthy
Being tested: Rivaroxaban, Tranexamic acid, Kcentra, a 4-factor PCC, Saline
Keywords: Healthy, Rivaroxaban, XARELTO

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RivaroxabanDrug
A single dose of 20 milligram (mg) of rivaroxaban orally will be administered to participants on Day 1 in part 1 and through day 1 and 3 with a final 20 mg dose administered on the morning of Day 4 in part 2.
Tranexamic acidDrug
1.0 g single dose of tranexamic acid (TXA), intravenously administered (over 10 mins) on Day 4.
Kcentra, a 4-factor PCCDrug
Kcentra, a 4-factor PCC, 50 IU/kg, single dose, intravenously administered (maximum rate of 210 [international units] IU/min) on Day 4.
SalineDrug
Saline [Kcentra saline control or TXA saline control] on Day 4.

Study groups in NCT02561923
Study group	Role	What they receive
Rivaroxaban	Experimental	Participants will be administered a single 20 milligram (mg) dose of rivaroxaban orally on Day 1 in Part 1. Receives: Drug: Rivaroxaban
Rivaroxaban plus tranexamic acid (TXA)	Experimental	Participants will be administered rivaroxaban (20 mg every 12 hrs) on Days 1 through 3 and a single 20 mg dose will be given on the morning of Day 4, all doses given orally. Following rivaroxaban adminsitration on Day 4, tranexamic acid (TXA) 1.0 gram (g) - (over 10 mins) intravenously administered on Day 4 in Part 2. Receives: Drug: Rivaroxaban; Drug: Tranexamic acid
Rivaroxaban plus Kcentra	Experimental	Participants will be administered rivaroxaban (20 mg every 12 hrs) on Days 1 through 3 and a single 20 mg dose will be given on the morning of Day 4, all doses given orally. Following rivaroxaban adminsitration on Day 4, participants will be randomized to receive a single dose of Kcentra (a 4-factor PCC), 50 international units per kilogram (IU/kg), intravenously administered (maximum rate of 210 [international units per minute] IU/min) on Day 4 in Part 2. Receives: Drug: Rivaroxaban; Drug: Kcentra, a 4-factor PCC
Rivaroxaban plus Saline	Experimental	Participants will be administered rivaroxaban (20 mg every 12 hrs) on Days 1 through 3 and a single 20 mg dose will be given on the morning of Day 4, all doses given orally. Following rivaroxaban adminsitration on Day 4, saline [Kcentra saline control or TXA saline control] on Day 4 in Part 2. Receives: Drug: Rivaroxaban; Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Blood Volume in Part 1
Volume of blood (BV) collected after a punch biopsy is performed.
Measured: Day-1 (Baseline) and 4 hour (hr) postdose on Day 1
Change From Baseline in Bleeding Duration in Part 1
Bleeding duration (BD) after a punch biopsy is performed.
Measured: Day-1 (Baseline) and 4 hr postdose on Day 1
Mean Change in Thrombin Generation Assay (TGA) - Endogenous Thrombin Potential (ETP) Lag-time in Part 2
The thrombin generation assay (TGA) is based on the premise that measurements of thrombin generation are indicative of the overall coagulating capacity of the individual. The data derived from the thrombography can be used to determine the ETP, which in turn provides a functional assessment of the overall clotting cascade. Change in lag time (time required until thrombin is generated) will be observed.
Measured: Predose (Baseline) and up to 72 hrs postdose on Day 4
Mean Change in Thrombin Generation Assay (TGA) - Endogenous Thrombin Potential (ETP) Peak in Part 2
The thrombin generation assay (TGA) is based on the premise that measurements of thrombin generation are indicative of the overall coagulating capacity of the individual. The data derived from the thrombography can be used to determine the ETP, which in turn provides a functional assessment of the overall clotting cascade. Change in peak (the maximal effect on thrombin generation) will be observed.
Measured: Predose (Baseline) and 72 hours postdose on Day 4
Mean Change in Thrombin Generation Assay (TGA) - Endogenous Thrombin Potential (ETP) Time to Peak in Part 2
The thrombin generation assay (TGA) is based on the premise that measurements of thrombin generation are indicative of the overall coagulating capacity of the individual. The data derived from the thrombography can be used to determine the ETP, which in turn provides a functional assessment of the overall clotting cascade. Change in time-to-peak (time required to reach maximal effect on thrombin generation) will be observed.
Measured: Predose (Baseline) and 72 hours postdose on Day 4
Mean Change in Thrombin Generation Assay (TGA) - Endogenous Thrombin Potential (ETP) Area Under Curve (AUC) in Part 2
The thrombin generation assay (TGA) is based on the premise that measurements of thrombin generation are indicative of the overall coagulating capacity of the individual. The data derived from the thrombography can be used to determine the ETP, which in turn provides a functional assessment of the overall clotting cascade. Change in AUC (the overall effect on thrombin generation) will be observed.
Measured: Predose (Baseline) up to 72 hours on Day 4
Mean Change in Prothrombin Time (PT) in Part 2
Prothrombin Time is a global clotting test that is used for the assessment of the extrinsic pathway of the blood coagulation cascade.
Measured: Predose (Baseline) up to 72 hours on Day 4
Change From Baseline in Blood Volume in Part 2
Measured: Predose (Baseline) and 72 hours on Day 4
Change From Baseline in Bleeding Duration in Part 2
Measured: Predose (Baseline) and 72 hours on Day 4

Secondary outcomes (14)

Maximum Observed Plasma Concentration (Cmax) in Part 1
Measured: Predose and up to 24 hrs postdose on Day 1
Time to Maximum Observed Plasma Concentration in Part 1 (Tmax)
Measured: Predose and up to 24 hrs post-dose
Area under Plasma Concentration Time Curve From Time 0 to 24 in Part 1 (AUC [0 TO 24]
Measured: Predose and up to 24 hrs postdose on Day 1
Maximum Observed Plasma Concentration (Cmax) in Part 2
Measured: Predose and up to 72 hrs postdose on Day 4
Minimum Observed Plasma Concentration (Cmin) in Part 2
Measured: Predose Days 1 to 4
Time to Maximum Observed Plasma Concentration (Tmax) in Part 2
Measured: Predose and up to 72 hrs postdose on Day 4
Area under plasma concentration time curve during the dosing interval (AUCtau) in Part 2
Measured: Predose and up to 24 hours
Mean Change in Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) Lag-time in Part 1
The thrombin generation assay (TGA) is based on the premise that measurements of thrombin generation are indicative of the overall coagulating capacity of the individual. The data derived from the thrombography can be used to determine the ETP, which in turn provides a functional assessment of the overall clotting cascade. Change in lag time (time required until thrombin is generated) will be observed.
Measured: Predose (Baseline) up to 24 hours on Day 1
Mean Change in Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) Peak in Part 1
The thrombin generation assay (TGA) is based on the premise that measurements of thrombin generation are indicative of the overall coagulating capacity of the individual. The data derived from the thrombography can be used to determine the ETP, which in turn provides a functional assessment of the overall clotting cascade. Change in peak (the maximal effect on thrombin generation) will be observed.
Measured: Predose (Baseline) up to 24 hours on Day 1
Mean Change in Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) Time to Peak in Part 1
The thrombin generation assay (TGA) is based on the premise that measurements of thrombin generation are indicative of the overall coagulating capacity of the individual. The data derived from the thrombography can be used to determine the ETP, which in turn provides a functional assessment of the overall clotting cascade. Change in time-to-peak (time required to reach maximal effect on thrombin generation) will be observed.
Measured: Predose (Baseline) up to 24 hours on Day 1
Mean Change in Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) Area Under Curve (AUC) in Part 1
The thrombin generation assay (TGA) is based on the premise that measurements of thrombin generation are indicative of the overall coagulating capacity of the individual. The data derived from the thrombography can be used to determine the ETP, which in turn provides a functional assessment of the overall clotting cascade. Change in AUC (the overall effect on thrombin generation) will be observed.
Measured: Predose (Baseline) up to 24 hours on Day 1
Mean Change in Prothrombin Time (PT) in Part 1
Prothrombin Time is a global clotting test that is used for the assessment of the extrinsic pathway of the blood coagulation cascade.
Measured: Predose (Baseline) up to 24 hours on Day 1
Trough Plasma Concentration (Ctrough) in Part 2
Ctrough is the trough plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose.
Measured: Predose and up to 72 hrs postdose on Day 4
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: Up to 37 Days (Part 1) and Up to 40 Days (Part 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Aug 201517 Jun 2016

First posted28 Sep 2015 (estimated)
Study start27 Aug 2015
Primary completion17 Jun 2016
Study completion17 Jun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 158 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02561923
Sponsor's protocol ID: CR107832
Other IDs: 39039039NAP1004
Status last verified: Jan 2025
First submitted: 21 Aug 2015
Last updated: 3 Feb 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Parallel-Group, 2-Part Study to Assess the Independent Effects of 4-Factor Prothrombin Complex Concentrate and Tranexamic Acid on Bleeding Parameters and Pharmacodynamics After a Punch Biopsy Procedure in Healthy Subjects Treated With Rivaroxaban
ClinicalTrials.gov ID: NCT02561923
Acronym / sponsor ID: CR107832
Conditions: Healthy
Keywords: Healthy, Rivaroxaban, XARELTO
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 158 participants (actual)
Lead sponsor: Janssen Scientific Affairs, LLCIndustry (pharma, biotech, devices)
Collaborators: Bayer
Study start: 27 Aug 2015 (actual)
Primary completion: 17 Jun 2016 (actual)
Study completion: 17 Jun 2016 (actual)
First posted: 28 Sep 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Rivaroxaban	Experimental	Drug: RivaroxabanParticipants will be administered a single 20 milligram (mg) dose of rivaroxaban orally on Day 1 in Part 1.
Rivaroxaban plus tranexamic acid (TXA)	Experimental	Drug: Rivaroxaban, Drug: Tranexamic acidParticipants will be administered rivaroxaban (20 mg every 12 hrs) on Days 1 through 3 and a single 20 mg dose will be given on the morning of Day 4, all doses given orally. Following rivaroxaban adminsitration on Day 4, tranexamic acid (TXA) 1.0 gram (g) - (over 10 mins) intravenously administered on Day 4 in Part 2.
Rivaroxaban plus Kcentra	Experimental	Drug: Rivaroxaban, Drug: Kcentra, a 4-factor PCCParticipants will be administered rivaroxaban (20 mg every 12 hrs) on Days 1 through 3 and a single 20 mg dose will be given on the morning of Day 4, all doses given orally. Following rivaroxaban adminsitration on Day 4, participants will be randomized to receive a single dose of Kcentra (a 4-factor PCC), 50 international units per kilogram (IU/kg), intravenously administered (maximum rate of 210 [international units per minute] IU/min) on Day 4 in Part 2.
Rivaroxaban plus Saline	Experimental	Drug: Rivaroxaban, Drug: SalineParticipants will be administered rivaroxaban (20 mg every 12 hrs) on Days 1 through 3 and a single 20 mg dose will be given on the morning of Day 4, all doses given orally. Following rivaroxaban adminsitration on Day 4, saline [Kcentra saline control or TXA saline control] on Day 4 in Part 2.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Body mass index (weight kilogram [kg]/height^2 meters [m]^2) between 18 and 30 kg/m2 (inclusive), and body weight between 50 and 100 kg;
Participants must have coagulation test results of prothrombin time (PT) and a partial thromboplastin time (PTT) within normal limits at Screening
Must have normal renal function, as per medical history
If a woman, must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (eg, double-barrier method or male partner sterilization) before entry and throughout the study. (Note: combined hormonal contraception should not be used)
Non-smoker (Note: subjects should not have used nicotine-containing products within 30 days before study drug administration)

Key exclusion criteria (9 listed)

History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease (including history of definite myocardial infarction, cerebrovascular accident, percutaneous transluminal coronary angioplasty or coronary artery bypass graft within 6 months before the Screening visit, or a previous intracranial hemorrhage at any time, known history of lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, seizure disorder, infection, skin disease, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
Participants with any history of thrombosis, inherited or acquired thrombophilia, bleeding diathesis or coagulopathy (including any abnormal bleeding or blood dyscrasias), hematologic disease, clinically significant hemorrhagic disorder, excessive bruising, bleeding from nose or gums or known disorders with increased bleeding risk (eg, acute gastritis, acute peptic ulcer), serious bleeding including gastrointestinal bleeding requiring hospitalization, intracranial bleeding of any type, or uncontrollable postoperative bleeding
Known antithrombin III, Protein C, or Protein S deficiency, Factor V Leiden or prothrombin gene 20210 mutation, anticardiolipin (immunoglobulin G [IgG] and immunoglobulin M [IgM]) or antiphospholipid antibodies, or family history of unexplained thrombotic disorders
History of intracranial tumor or aneurysm or known abdominal aneurysm
Clinically significant abnormal physical examination, vital signs or 12-lead electrocardigram [ECG] at Screening or at admission to the study center on Day -1, as deemed appropriate by the investigator. This would include: resting pulse >100 or <40 beats per min, blood pressure systolic >140 or <90 millimeters per mercuric level [mmHg], and diastolic blood pressure > 90 or < 50 mmHg (pulse and blood pressure measurements should be taken in a supine position, after resting for at least 5 minutes)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RivaroxabanA single dose of 20 milligram (mg) of rivaroxaban orally will be administered to participants on Day 1 in part 1 and through day 1 and 3 with a final 20 mg dose administered on the morning of Day 4 in part 2.	Drug	Rivaroxaban, Rivaroxaban plus Kcentra, Rivaroxaban plus Saline, Rivaroxaban plus tranexamic acid (TXA)
Tranexamic acid1.0 g single dose of tranexamic acid (TXA), intravenously administered (over 10 mins) on Day 4.	Drug	Rivaroxaban plus tranexamic acid (TXA)
Kcentra, a 4-factor PCCKcentra, a 4-factor PCC, 50 IU/kg, single dose, intravenously administered (maximum rate of 210 [international units] IU/min) on Day 4.	Drug	Rivaroxaban plus Kcentra
SalineSaline [Kcentra saline control or TXA saline control] on Day 4.	Drug	Rivaroxaban plus Saline

Primary outcome

Change From Baseline in Blood Volume in Part 1
Time frame: Day-1 (Baseline) and 4 hour (hr) postdose on Day 1
Volume of blood (BV) collected after a punch biopsy is performed.
Change From Baseline in Bleeding Duration in Part 1
Time frame: Day-1 (Baseline) and 4 hr postdose on Day 1
Bleeding duration (BD) after a punch biopsy is performed.
Mean Change in Thrombin Generation Assay (TGA) - Endogenous Thrombin Potential (ETP) Lag-time in Part 2
Time frame: Predose (Baseline) and up to 72 hrs postdose on Day 4
The thrombin generation assay (TGA) is based on the premise that measurements of thrombin generation are indicative of the overall coagulating capacity of the individual. The data derived from the thrombography can be used to determine the ETP, which in turn provides a functional assessment of the overall clotting cascade. Change in lag time (time required until thrombin is generated) will be observed.
Mean Change in Thrombin Generation Assay (TGA) - Endogenous Thrombin Potential (ETP) Peak in Part 2
Time frame: Predose (Baseline) and 72 hours postdose on Day 4
The thrombin generation assay (TGA) is based on the premise that measurements of thrombin generation are indicative of the overall coagulating capacity of the individual. The data derived from the thrombography can be used to determine the ETP, which in turn provides a functional assessment of the overall clotting cascade. Change in peak (the maximal effect on thrombin generation) will be observed.
Mean Change in Thrombin Generation Assay (TGA) - Endogenous Thrombin Potential (ETP) Time to Peak in Part 2
Time frame: Predose (Baseline) and 72 hours postdose on Day 4
The thrombin generation assay (TGA) is based on the premise that measurements of thrombin generation are indicative of the overall coagulating capacity of the individual. The data derived from the thrombography can be used to determine the ETP, which in turn provides a functional assessment of the overall clotting cascade. Change in time-to-peak (time required to reach maximal effect on thrombin generation) will be observed.
Mean Change in Thrombin Generation Assay (TGA) - Endogenous Thrombin Potential (ETP) Area Under Curve (AUC) in Part 2
Time frame: Predose (Baseline) up to 72 hours on Day 4
The thrombin generation assay (TGA) is based on the premise that measurements of thrombin generation are indicative of the overall coagulating capacity of the individual. The data derived from the thrombography can be used to determine the ETP, which in turn provides a functional assessment of the overall clotting cascade. Change in AUC (the overall effect on thrombin generation) will be observed.
Mean Change in Prothrombin Time (PT) in Part 2
Time frame: Predose (Baseline) up to 72 hours on Day 4
Prothrombin Time is a global clotting test that is used for the assessment of the extrinsic pathway of the blood coagulation cascade.
Change From Baseline in Blood Volume in Part 2
Time frame: Predose (Baseline) and 72 hours on Day 4
Change From Baseline in Bleeding Duration in Part 2
Time frame: Predose (Baseline) and 72 hours on Day 4

14 secondary outcomes

Maximum Observed Plasma Concentration (Cmax) in Part 1
Time frame: Predose and up to 24 hrs postdose on Day 1
Time to Maximum Observed Plasma Concentration in Part 1 (Tmax)
Time frame: Predose and up to 24 hrs post-dose
Area under Plasma Concentration Time Curve From Time 0 to 24 in Part 1 (AUC [0 TO 24]
Time frame: Predose and up to 24 hrs postdose on Day 1
Maximum Observed Plasma Concentration (Cmax) in Part 2
Time frame: Predose and up to 72 hrs postdose on Day 4
Minimum Observed Plasma Concentration (Cmin) in Part 2
Time frame: Predose Days 1 to 4
Time to Maximum Observed Plasma Concentration (Tmax) in Part 2
Time frame: Predose and up to 72 hrs postdose on Day 4
Area under plasma concentration time curve during the dosing interval (AUCtau) in Part 2
Time frame: Predose and up to 24 hours
Mean Change in Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) Lag-time in Part 1
Time frame: Predose (Baseline) up to 24 hours on Day 1
Mean Change in Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) Peak in Part 1
Time frame: Predose (Baseline) up to 24 hours on Day 1
Mean Change in Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) Time to Peak in Part 1
Time frame: Predose (Baseline) up to 24 hours on Day 1
Mean Change in Thrombin Generation Assay (TGA) Endogenous Thrombin Potential (ETP) Area Under Curve (AUC) in Part 1
Time frame: Predose (Baseline) up to 24 hours on Day 1
Mean Change in Prothrombin Time (PT) in Part 1
Time frame: Predose (Baseline) up to 24 hours on Day 1
Trough Plasma Concentration (Ctrough) in Part 2
Time frame: Predose and up to 72 hrs postdose on Day 4
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 37 Days (Part 1) and Up to 40 Days (Part 2)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
Randomized,Parallel-Group,2-Part Study to Assess the Independent Effects of 4-Factor Prothrombin Complex Concentrate and Tranexamic Acid on Bleeding Parameters and Pharmacodynamics After Punch Biopsy Procedure in Healthy Subjects Treated With RivaroxabanLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janssen Scientific Affairs, LLC Clinical Trial study director

Janssen Scientific Affairs, LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rivaroxaban, Tranexamic acid and Kcentra, a 4-factor PCC in people with Healthy, run by Janssen Scientific Affairs, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Blood Volume in Part 1 (time frame: Day-1 (Baseline) and 4 hour (hr) postdose on Day 1). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02561923.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.