HealthyPhase 1NCT01309438
A Study of Erythromycin and Rivaroxaban in Study Participants With Normal and Reduced Kidney Function
A Phase 1 study testing Rivaroxaban (normal renal function), Rivaroxaban (mild and moderate renal impairment) and Erythromycin (normal renal function) in people with Healthy and Renal Insufficiency, run by Janssen Research & Development, LLC at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Renal Insufficiency
- What is being tested?
- Rivaroxaban (normal renal function), Rivaroxaban (mild and moderate renal impairment) and Erythromycin (normal renal function)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2011to Mar 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Study site
Knoxville, Tennessee
Study site
Minneapolis, Minnesota
Study site
Orlando, Florida
Study site
Saint Paul, Minnesota
About this study
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
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.
Read the 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.
- Conditions
- Healthy, Renal Insufficiency
- Being tested
- Rivaroxaban (normal renal function), Rivaroxaban (mild and moderate renal impairment), Erythromycin (normal renal function), Erythromycin (mild and moderate renal function)
- Keywords
- Healthy, Renal Insufficiency, Rivaroxaban (BAY 59-7939, JNJ-39039039), Erythromycin, Pharmacokinetic, Pharmacodynamic
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
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
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: Drug: Rivaroxaban (mild and moderate renal impairment); Drug: Erythromycin (mild and moderate renal function) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rivaroxaban plasma concentrations
Measured: Up to Day 7 of Treatment Period 3
Erythromycin plasma concentrations
Measured: Up to Day 7 of Treatment Period 3
Rivaroxaban urine concentrations
Measured: Up to Day 7 of Treatment Period 3
Secondary outcomes (2)
The number of patients with adverse events reported
Measured: Up to 48 hours after Day 7 of Treatment Period 3
Coagulation tests (prothrombin time [PT] and activated partial thromboplastin time [aPTT])
Measured: Up to Day 6 of Treatment Period 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309438
- Sponsor's protocol ID
- CR017968
- Other IDs
- RIVAROXACS1001
- Status last verified
- Oct 2014
- First submitted
- 17 Feb 2011
- Last updated
- 8 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01309438
- Acronym / sponsor ID
- CR017968
- Conditions
- Healthy, Renal Insufficiency
- Keywords
- Healthy, Renal Insufficiency, Rivaroxaban (BAY 59-7939, JNJ-39039039), Erythromycin, Pharmacokinetic, Pharmacodynamic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Bayer
- Study start
- Feb 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 7 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal renal function | Experimental | Drug: Rivaroxaban (normal renal function), Drug: Erythromycin (normal renal function)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) |
| Mild renal impairment | Experimental | Drug: Rivaroxaban (mild and moderate renal impairment), Drug: Erythromycin (mild and moderate renal function)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) |
| Moderate renal impairment | Experimental | Drug: Rivaroxaban (mild and moderate renal impairment), Drug: Erythromycin (mild and moderate renal function)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) |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban (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 | Drug | Normal renal function |
| Rivaroxaban (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 | Drug | Mild renal impairment, Moderate renal impairment |
| Erythromycin (normal renal function)One 500 mg tablet taken orally (by mouth) three times daily on Days 1 to 6 of Treatment Period 2 | Drug | Normal renal function |
| Erythromycin (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 | Drug | Mild renal impairment, Moderate renal impairment |
Primary outcome
Rivaroxaban plasma concentrations
Time frame: Up to Day 7 of Treatment Period 3
Erythromycin plasma concentrations
Time frame: Up to Day 7 of Treatment Period 3
Rivaroxaban urine concentrations
Time frame: Up to Day 7 of Treatment Period 3
2 secondary outcomes
The number of patients with adverse events reported
Time frame: Up to 48 hours after Day 7 of Treatment Period 3
Coagulation tests (prothrombin time [PT] and activated partial thromboplastin time [aPTT])
Time frame: Up to Day 6 of Treatment Period 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2014.
- 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 FunctionLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rivaroxaban (normal renal function), Rivaroxaban (mild and moderate renal impairment) and Erythromycin (normal renal function) in people with Healthy and Renal Insufficiency, run by Janssen Research & Development, LLC at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rivaroxaban plasma concentrations (time frame: Up to Day 7 of Treatment Period 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2014.