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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-27

Study Completion Date

2016-06-17

Brief Summary

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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.

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Detailed Description

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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

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Rivaroxaban

Participants will be administered a single 20 milligram (mg) dose of rivaroxaban orally on Day 1 in Part 1.

Group Type EXPERIMENTAL

Rivaroxaban

Intervention Type DRUG

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.

Rivaroxaban plus tranexamic acid (TXA)

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.

Group Type EXPERIMENTAL

Rivaroxaban

Intervention Type DRUG

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 acid

Intervention Type DRUG

1.0 g single dose of tranexamic acid (TXA), intravenously administered (over 10 mins) on Day 4.

Rivaroxaban plus Kcentra

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.

Group Type EXPERIMENTAL

Rivaroxaban

Intervention Type DRUG

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.

Kcentra, a 4-factor PCC

Intervention Type DRUG

Kcentra, a 4-factor PCC, 50 IU/kg, single dose, intravenously administered (maximum rate of 210 \[international units\] IU/min) on Day 4.

Rivaroxaban plus Saline

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.

Group Type EXPERIMENTAL

Rivaroxaban

Intervention Type DRUG

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.

Saline

Intervention Type DRUG

Saline \[Kcentra saline control or TXA saline control\] on Day 4.

Interventions

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Rivaroxaban

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.

Intervention Type DRUG

Tranexamic acid

1.0 g single dose of tranexamic acid (TXA), intravenously administered (over 10 mins) on Day 4.

Intervention Type DRUG

Kcentra, a 4-factor PCC

Kcentra, a 4-factor PCC, 50 IU/kg, single dose, intravenously administered (maximum rate of 210 \[international units\] IU/min) on Day 4.

Intervention Type DRUG

Saline

Saline \[Kcentra saline control or TXA saline control\] on Day 4.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes