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A Study of Erythromycin and Rivaroxaban in Study Participants With Normal and Reduced Kidney Function

Primary Purpose

Healthy, Renal Insufficiency

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Rivaroxaban (normal renal function)
Rivaroxaban (mild and moderate renal impairment)
Erythromycin (normal renal function)
Erythromycin (mild and moderate renal function)
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy focused on measuring Healthy, Renal Insufficiency, Rivaroxaban (BAY 59-7939, JNJ-39039039), Erythromycin, Pharmacokinetic, Pharmacodynamic

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Have a body mass index (BMI) between 18 and 38 kg/m2, inclusive
  • Have a body weight of not less than 50 kg and have been characterized as having normal renal function (creatinine clearance [CLCR] > 80 mL/min), mild renal impairment (CLCR 50-79 mL/min) or moderate renal impairment (CLCR 30-49 mL/min)
  • Study participants with renal impairment should have stable renal disease as determined by the Investigator

Exclusion Criteria:

  • History of current clinically significant medical illness or any other illness that the Investigator considers should exclude the study participant or that could interfere with the interpretation of the study results
  • Additional exclusion criteria for study participants with normal renal function include: diastolic blood pressure > 95 mm Hg and/or systolic blood pressure > 150 mm Hg)
  • Additional exclusion criteria for study participants with renal impairment include: diastolic blood pressure > 100 mm Hg and/or systolic blood pressure > 170 mm Hg, other routine laboratory parameters > upper limit of normal which could not be explained by the underlying renal disease unless judged to be clinically unimportant by the investigator, have acute renal failure, or be a recipient of transplanted organs
  • Have severe renal impairment (CLCR < 30 mL/min)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Normal renal function

Mild renal impairment

Moderate renal impairment

Arm Description

Treatment Period 1 (1 dose of 10 mg rivaroxaban on Day 1) followed, up to 14 days later, by Treatment Period 2 (500 mg erythromycin three times daily on Days 1 to 6 plus 1 dose of 10 mg rivaroxaban on Day 5)

Treatment Period 1 (1 dose of 10 mg rivaroxaban on Day 1) followed, up to 14 days later, by Treatment Period 2 (500 mg erythromycin three times daily on Days 1 to 6 plus 1 dose of 5 mg rivaroxaban on Day 5) followed, up to 14 days later, by Treatment Period 3 (500 mg erythromycin three times daily on Days 1 to 6 plus 1 dose of 10 mg rivaroxaban on Day 5)

Treatment Period 1 (1 dose of 10 mg rivaroxaban on Day 1) followed, up to 14 days later, by Treatment Period 2 (500 mg erythromycin three times daily on Days 1 to 6 plus 1 dose of 5 mg rivaroxaban on Day 5) followed, up to 14 days later, by Treatment Period 3 (500 mg erythromycin three times daily on Days 1 to 6 plus 1 dose of 10 mg rivaroxaban on Day 5)

Outcomes

Primary Outcome Measures

Rivaroxaban plasma concentrations
Erythromycin plasma concentrations
Rivaroxaban urine concentrations

Secondary Outcome Measures

The number of patients with adverse events reported
Coagulation tests (prothrombin time [PT] and activated partial thromboplastin time [aPTT])

Full Information

First Posted
February 17, 2011
Last Updated
October 7, 2014
Sponsor
Janssen Research & Development, LLC
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT01309438
Brief Title
A Study of Erythromycin and Rivaroxaban in Study Participants With Normal and Reduced Kidney Function
Official Title
An Open-Label Study to Estimate the Effect of Multiple Doses of Erythromycin on the Pharmacokinetics, Pharmacodynamics and Safety of a Single Dose of Rivaroxaban in Subjects With Renal Impairment and Normal Renal Function
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
Collaborators
Bayer

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of rivaroxaban when administered with erythromycin to study participants with mild or moderate renal impairment compared to the pharmacokinetics and pharmacodynamics of rivaroxaban administered to study participants with normal renal function.
Detailed Description
This is an open-label study (participants and the study physician [Investigator] will know the identity of the assigned treatments) to compare the pharmacokinetics (PK) (how the drugs are absorbed in the body) and pharmacodynamics (PD) (the actions or effects of drugs on the body) of rivaroxaban in study participants with mild or moderate renal impairment (reduced kidney function) receiving multiple doses of erythromycin, to the PK and PD of a single dose of rivaroxaban administered alone in study participants with normal renal function. The study drugs used will be rivaroxaban, a drug that acts to thin the blood to prevent the formation of blood clots, and erythromycin, an antibiotic used to treat patients with bacterial infections. Study participants with normal renal function will receive Treatment A (1 oral [by mouth] dose 10 mg rivaroxaban for 1 day) and Treatment C (500 mg oral erythromycin 3x a day (t.i.d.) on Days 1-6 + 1 oral dose of 10 mg rivaroxaban on Day 5). Study participants with mild and moderate renal impairment will receive Treatment A, Treatment B (500 mg oral erythromycin t.i.d. on Days 1-6 + 1 oral dose of 5 mg rivaroxaban Day 5), and Treatment C. Treatments A, B, and C will be separated by up to 14 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Renal Insufficiency
Keywords
Healthy, Renal Insufficiency, Rivaroxaban (BAY 59-7939, JNJ-39039039), Erythromycin, Pharmacokinetic, Pharmacodynamic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal renal function
Arm Type
Experimental
Arm Description
Treatment Period 1 (1 dose of 10 mg rivaroxaban on Day 1) followed, up to 14 days later, by Treatment Period 2 (500 mg erythromycin three times daily on Days 1 to 6 plus 1 dose of 10 mg rivaroxaban on Day 5)
Arm Title
Mild renal impairment
Arm Type
Experimental
Arm Description
Treatment Period 1 (1 dose of 10 mg rivaroxaban on Day 1) followed, up to 14 days later, by Treatment Period 2 (500 mg erythromycin three times daily on Days 1 to 6 plus 1 dose of 5 mg rivaroxaban on Day 5) followed, up to 14 days later, by Treatment Period 3 (500 mg erythromycin three times daily on Days 1 to 6 plus 1 dose of 10 mg rivaroxaban on Day 5)
Arm Title
Moderate renal impairment
Arm Type
Experimental
Arm Description
Treatment Period 1 (1 dose of 10 mg rivaroxaban on Day 1) followed, up to 14 days later, by Treatment Period 2 (500 mg erythromycin three times daily on Days 1 to 6 plus 1 dose of 5 mg rivaroxaban on Day 5) followed, up to 14 days later, by Treatment Period 3 (500 mg erythromycin three times daily on Days 1 to 6 plus 1 dose of 10 mg rivaroxaban on Day 5)
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban (normal renal function)
Intervention Description
One 10 mg tablet of rivaroxaban taken orally (by mouth) on Day 1 of Treatment Period 1; One 10 mg tablet of rivaroxaban taken orally on Day 5 of Treatment Period 2
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban (mild and moderate renal impairment)
Intervention Description
One 10 mg tablet of rivaroxaban taken orally (by mouth) on Day 1 of Treatment Period 1; One 5 mg tablet of rivaroxaban taken orally on Day 5 of Treatment Period 2; One 10 mg tablet of rivaroxaban taken orally on Day 5 of Treatment Period 3
Intervention Type
Drug
Intervention Name(s)
Erythromycin (normal renal function)
Intervention Description
One 500 mg tablet taken orally (by mouth) three times daily on Days 1 to 6 of Treatment Period 2
Intervention Type
Drug
Intervention Name(s)
Erythromycin (mild and moderate renal function)
Intervention Description
One 500 mg tablet taken orally (by mouth) three times daily on Days 1 to 6 of Treatment Periods 2 and 3
Primary Outcome Measure Information:
Title
Rivaroxaban plasma concentrations
Time Frame
Up to Day 7 of Treatment Period 3
Title
Erythromycin plasma concentrations
Time Frame
Up to Day 7 of Treatment Period 3
Title
Rivaroxaban urine concentrations
Time Frame
Up to Day 7 of Treatment Period 3
Secondary Outcome Measure Information:
Title
The number of patients with adverse events reported
Time Frame
Up to 48 hours after Day 7 of Treatment Period 3
Title
Coagulation tests (prothrombin time [PT] and activated partial thromboplastin time [aPTT])
Time Frame
Up to Day 6 of Treatment Period 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Have a body mass index (BMI) between 18 and 38 kg/m2, inclusive Have a body weight of not less than 50 kg and have been characterized as having normal renal function (creatinine clearance [CLCR] > 80 mL/min), mild renal impairment (CLCR 50-79 mL/min) or moderate renal impairment (CLCR 30-49 mL/min) Study participants with renal impairment should have stable renal disease as determined by the Investigator Exclusion Criteria: History of current clinically significant medical illness or any other illness that the Investigator considers should exclude the study participant or that could interfere with the interpretation of the study results Additional exclusion criteria for study participants with normal renal function include: diastolic blood pressure > 95 mm Hg and/or systolic blood pressure > 150 mm Hg) Additional exclusion criteria for study participants with renal impairment include: diastolic blood pressure > 100 mm Hg and/or systolic blood pressure > 170 mm Hg, other routine laboratory parameters > upper limit of normal which could not be explained by the underlying renal disease unless judged to be clinically unimportant by the investigator, have acute renal failure, or be a recipient of transplanted organs Have severe renal impairment (CLCR < 30 mL/min)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Orlando
State/Province
Florida
Country
United States
City
Minneapolis
State/Province
Minnesota
Country
United States
City
St. Paul
State/Province
Minnesota
Country
United States
City
Knoxville
State/Province
Tennessee
Country
United States

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=883&filename=CR017968_CSR.pdf
Description
An Open-Label Study to Estimate the Effect of Multiple Doses of Erythromycin on the Pharmacokinetics, Pharmacodynamics and Safety of a Single Dose of Rivaroxaban in Subjects with Renal Impairment and Normal Renal Function

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A Study of Erythromycin and Rivaroxaban in Study Participants With Normal and Reduced Kidney Function

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