Healthy, Renal Insufficiency
Conditions
Keywords
Healthy, Renal Insufficiency, Rivaroxaban (BAY 59-7939, JNJ-39039039), Erythromycin, Pharmacokinetic, Pharmacodynamic
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.
Interventions
DRUGRivaroxaban (normal renal function)
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
DRUGRivaroxaban (mild and moderate renal impairment)
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
DRUGErythromycin (normal renal function)
One 500 mg tablet taken orally (by mouth) three times daily on Days 1 to 6 of Treatment Period 2
DRUGErythromycin (mild and moderate renal function)
One 500 mg tablet taken orally (by mouth) three times daily on Days 1 to 6 of Treatment Periods 2 and 3
Sponsors
Bayer
Janssen Research & Development, LLC
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed