The purpose of this study is to assess the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) and pharmacodynamics (the way a drug may change body function) of a single 15-milligram (mg) dose of rivaroxaban in both healthy participants with a creatinine clearance (CLcr) greater than equal to (\>=) 80 milliliter per minute (mL/min) and clinically stable participants with end-stage renal disease (ESRD) on maintenance hemodialysis (a method used to remove waste material from the blood when the kidneys are unable to do so).
This is an open-label (participants and researchers are aware about the treatment, participants are receiving), single-dose, single-center, parallel group (a medical research study comparing the response in 2 or more groups of participants receiving different interventions) study. This study consists of a Screening Period (within 21 days prior to admission into the study center on Day -1), followed by 2 treatment periods for ESRD participants (Group A) (Treatment Period 1: rivaroxaban will be administered 2 hours before the start of a 4-hour hemodialysis session on Day 1; Treatment Period 2: rivaroxaban will be administered 3 hours after the completion of a 4-hour hemodialysis session on Day 1), or 1 treatment period for healthy participants (Group B) (single oral dose of rivaroxaban will be administered on Day 1). Each treatment period will have duration of 4 days. For ESRD participants, the 2 treatments periods will be separated by a washout period of at least 7 days and a maximum of 14 days. The total study duration for ESRD participants is approximately 43 days. The total study duration for healthy participants is approximately 25 days. Blood samples will be collected to assess pharmacokinetic and pharmacodynamic parameters. Participants' safety will be monitored throughout the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Single oral dose of rivaroxaban 15-mg tablet on Day 1 of each of the treatment periods.
Unnamed facility
Knoxville, Tennessee, United States
Maximum Observed Plasma Concentration (Cmax) of Rivaroxaban
The Cmax is the maximum observed plasma concentration.
Time frame: Pre-dose up to 72 hrs post-dose
Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Time (AUClast) of Rivaroxaban
The AUClast is the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration.
Time frame: Pre-dose up to 72 hrs post-dose
Area Under the Plasma Concentration-time Curve From Time Zero to Extrapolated Infinite Time (AUCinfinity) of Rivaroxaban
The AUCinfinity is the area under the plasma concentration-time curve from time zero to extrapolated infinite time, calculated as the sum of AUClast and Clast/lambda(z), where AUClast is area under the plasma concentration-time curve from time zero to time of last quantifiable plasma concentration; Clast is the last observed quantifiable concentration; and lambda(z) is first-order rate constant associated with the terminal portion of the semilogarithmic drug concentration-time curve.
Time frame: Pre-dose up to 72 hrs post-dose
Maximum Observed Effect (Emax) for Prothrombin Time (PT), Factor Xa (FXa) Inhibition and Anti-FXa
Maximum observed effect (Emax) for parameters: prothrombin time (PT), factor Xa (FXa) inhibition and anti-FXa, will be assessed.
Time frame: Pre-dose up to 72 hrs post-dose
Area Under the Dose-Response Curve for Prothrombin Time (PT), Factor Xa (FXa) Inhibition and Anti-FXa
The area under the dose-response curve for parameters: prothrombin time, FXa inhibition and anti-FXa, will be assessed.
Time frame: Pre-dose up to 72 hrs post-dose
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Screening up to end of study (Group A: maximum up to 43 days, Group B: maximum up to 25 days) or up to early withdrawal
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