Pharmacokinetics and Pharmacodynamics of Apixaban in Subjects on Hemodialysis

End Stage Renal Disease Clinical Trial

Official title:

Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Apixaban in Subjects on Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340586
• Other study ID #: CV185-087
• Status: Completed
• Phase: Phase 1
• First received: April 21, 2011
• Last updated: November 29, 2011
• Start date: June 2011
• Est. completion date: September 2011

Study information

• Verified date: July 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the pharmacokinetics of a single oral dose of 5 mg Apixaban in subjects with normal renal function and subjects with end stage renal disease (ESRD) maintained with hemodialysis.

Description:

Primary Purpose : To provide a clear understanding of the pharmacokinetics of Apixaban in subjects with ESRD and to determine the effect of hemodialysis on Apixaban pharmacokinetics .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• The signed informed consent form.

• Subjects with normal renal function classified based on calculated creatinine clearance determined by the cockcroft-gault calculation.

• Eligible subjects with ESRD that is maintained with chronic and stable hemodialysis.

Exclusion Criteria:

• Any history of abnormal bleeding or coagulation disorders including those in a first degree relative under 50 years of age.

• History of significant head injury within the last two years.

• Any gastrointestinal surgery that could impact the absorption of study drug.

• Not expected to continue the hemodialysis treatment for the duration of the study.

• INR, PT, or aPTT above the upper limit of normal, unless agreed upon between the investigator and BMS medical monitor.

• History of allergy to Apixaban or Factor Xa inhibitors.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• Apixaban
Tablets, Oral, 5 mg, Once, 4 days
• Apixaban
Tablets, Oral, 5 mg, Twice, 15 days

Locations

Country	Name	City	State
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the pharmacokinetics (PK) of a single oral dose of 5 mg Apixaban in subjects with normal renal function and subjects with ESRD maintained with hemodialysis.		Blood, urine, and dialysate samples will be collected for PK analysis pre-dose, during the hemodialysis session, and for up to 72 hours post dose.	No
Secondary	Assess the effect of hemodialysis on the PK of Apixaban following a single oral dose of 5 mg.		Blood, urine, and dialysate samples will be collected for PK analysis pre-dose, during the hemodialysis session, and for up to 72 hours post dose.	No
Secondary	Assess the effect of a single oral dose of 5 mg Apixaban on international normalized ratio (INR) in subjects with normal renal function and subjects with ESRD maintained with hemodialysis.		Blood samples will be collected for pharmacodynamic (PD) analysis pre-dose, during the hemodialysis session, and until study discharge	No
Secondary	Assess the effect of a single oral dose of 5 mg Apixaban on prothrombin time (PT) in subjects with normal renal function and subjects with ESRD maintained with hemodialysis.		Blood samples will be collected for pharmacodynamic (PD) analysis pre-dose, during the hemodialysis session, and until study discharge	No
Secondary	Assess the effect of a single oral dose of 5 mg Apixaban on activated partial thromboplastin time (aPTT) in subjects with normal renal function and subjects with ESRD maintained with hemodialysis.		Blood samples will be collected for pharmacodynamic (PD) analysis pre-dose, during the hemodialysis session, and until study discharge	No
Secondary	Assess the effect of a single oral dose of 5 mg Apixaban on anti-FXa activity in subjects with normal renal function and subjects with ESRD maintained with hemodialysis.		Blood samples will be collected for pharmacodynamic (PD) analysis pre-dose, during the hemodialysis session, and until study discharge	No
Secondary	Assess the safety and tolerability of a single oral dose of 5 mg Apixaban in subjects with normal renal function and subjects with ESRD maintained with hemodialysis.		Subjects will be closely monitored for adverse events from the initiation of study drug until study discharge (approximately 15 days) and will be followed to resolution or stabilization.	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form