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

NCT01309438 | Completed Phase 1

• 2 other identifiers: CR017968RIVAROXACS1001
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 4

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.

Conditions

Healthy; Renal Insufficiency

Keywords

Healthy; Renal Insufficiency; Rivaroxaban (BAY 59-7939, JNJ-39039039); Erythromycin; Pharmacokinetic; Pharmacodynamic

Outcome Measures

Primary Outcomes (3)

• Rivaroxaban plasma concentrations

  Up to Day 7 of Treatment Period 3

• Erythromycin plasma concentrations

  Up to Day 7 of Treatment Period 3

• Rivaroxaban urine concentrations

  Up to Day 7 of Treatment Period 3

Secondary Outcomes (2)

• The number of patients with adverse events reported

  Up to 48 hours after Day 7 of Treatment Period 3

• Coagulation tests (prothrombin time [PT] and activated partial thromboplastin time [aPTT])

  Up to Day 6 of Treatment Period 3

Study Arms (3)

Normal renal function

EXPERIMENTAL

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)

Drug: Rivaroxaban (normal renal function); Drug: Erythromycin (normal renal function)

Mild renal impairment

EXPERIMENTAL

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)

Drug: Rivaroxaban (mild and moderate renal impairment); Drug: Erythromycin (mild and moderate renal function)

Moderate renal impairment

EXPERIMENTAL

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)

Drug: Rivaroxaban (mild and moderate renal impairment); Drug: Erythromycin (mild and moderate renal function)

Interventions

Rivaroxaban (normal renal function) DRUG

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

Normal renal function

Rivaroxaban (mild and moderate renal impairment) DRUG

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

Mild renal impairment; Moderate renal impairment

Erythromycin (normal renal function) DRUG

One 500 mg tablet taken orally (by mouth) three times daily on Days 1 to 6 of Treatment Period 2

Normal renal function

Erythromycin (mild and moderate renal function) DRUG

One 500 mg tablet taken orally (by mouth) three times daily on Days 1 to 6 of Treatment Periods 2 and 3

Mild renal impairment; Moderate renal impairment

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Have severe renal impairment (CLCR \< 30 mL/min)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead
• Bayer: collaborator

Study Sites (4)

Unknown Facility

Orlando, Florida, United States

Location

Unknown Facility

Minneapolis, Minnesota, United States

Location

Unknown Facility

Saint Paul, Minnesota, United States

Location

Unknown Facility

Knoxville, Tennessee, United States

Location

Related Links

• 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

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Rivaroxaban; Erythromycin

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Macrolides; Polyketides; Lactones

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: March 7, 2011
• Study Start: February 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: October 8, 2014

Record last verified: 2014-10

Locations

US (4)