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

Completed · Phase 1

Conditions studied: Healthy, Renal Insufficiency

In brief

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.

Key facts

Study ID

NCT01309438

Run by

Janssen Research & Development, LLC

People needed

29

Starts

2011-02-01

Expected to finish

2012-03-01

Last updated by the study team

2014-10-08

Who can join

Age: 35 and older, up to 75. Sex: any. Healthy volunteers: accepted.

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
• 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)

Where it is running

• Study site — Orlando, Florida, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Saint Paul, Minnesota, United States
• Study site — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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