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| ID | Type | Description | Link |
|---|---|---|---|
| RIVAROXCRF1001 | Other Identifier | Janssen Research & Development, LLC |
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Participants with end-stage renal disease (ESRD), will receive a single 15-milligram (mg) oral dose of rivaroxaban in Treatment Period 1 on Day 1, administered 2 hours before the start of a 4-hour hemodialysis session followed 7 to 14 days later by Treatment Period 2 wherein a single 15-mg oral dose of rivaroxaban will be given 3 hours after the completion of a 4-hour hemodialysis session on Day 1. |
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| Group B | Experimental | Healthy control participants matching to 'Group A' participants, will receive a single 15-mg oral dose of rivaroxaban on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban 15 mg | Drug | Single oral dose of rivaroxaban 15-mg tablet on Day 1 of each of the treatment periods. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Rivaroxaban | The Cmax is the maximum observed plasma concentration. | 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. | 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. | Pre-dose up to 72 hrs post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
A. All Participants:
- Body mass index (BMI = weight in kilogram [kg] divided by the square of height in meter [m]) between 18 and 38 kg/m^2, extremes included, and body weight not less than 50 kg
B. Additional Inclusion Criteria for ESRD Participants (Group A):
C. Additional Inclusion Criteria for Healthy Matched Control Participants (Group B):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Knoxville | Tennessee | United States |
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| Label | URL |
|---|---|
| An Open-label Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of a Single Dose of Rivaroxaban in Subjects with End-Stage Renal Disease (ESRD) on Maintenance Hemodialysis | View source |
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The area under the dose-response curve for parameters: prothrombin time, FXa inhibition and anti-FXa, will be assessed. |
| 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. | 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 |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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