NCT02561923 - A Study to Assess the Independent Effects of 4-Factor Prothrombin Complex Concentrate and Tranexamic Acid on Bleeding/Pharmacodynamics in Healthy Participants | Biotech Hunter

Enrollment

158

Participants

Timeline

Start Date

August 27, 2015

Primary Completion Date

June 17, 2016

Study Completion Date

June 17, 2016

Conditions

Healthy

Interventions

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.

Trial Locations (1)

Unknown

Overland Park