NCT02561923

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Janssen Scientific Affairs, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

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

Interventions

Type	Name	Description
DRUG	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.
DRUG	Tranexamic acid	1.0 g single dose of tranexamic acid (TXA), intravenously administered (over 10 mins) on Day 4.
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.
DRUG	Saline	Saline \[Kcentra saline control or TXA saline control\] on Day 4.

Timeline

• Start date: 2015-08-27
• Primary completion: 2016-06-17
• Completion: 2016-06-17
• First posted: 2015-09-28
• Last updated: 2025-02-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study