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Pharmacokinetics and Pharmacodynamics of Apixaban in Subjects on Hemodialysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01340586
First received: April 21, 2011
Last updated: November 29, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
End Stage Renal Disease
 Drug: Apixaban
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Apixaban in Subjects on Hemodialysis

Resource links provided by NLM:

Drug Information available for: Apixaban
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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. [ Time Frame: 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the effect of hemodialysis on the PK of Apixaban following a single oral dose of 5 mg. [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Blood samples will be collected for pharmacodynamic (PD) analysis pre-dose, during the hemodialysis session, and until study discharge ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Blood samples will be collected for pharmacodynamic (PD) analysis pre-dose, during the hemodialysis session, and until study discharge ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Blood samples will be collected for pharmacodynamic (PD) analysis pre-dose, during the hemodialysis session, and until study discharge ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Blood samples will be collected for pharmacodynamic (PD) analysis pre-dose, during the hemodialysis session, and until study discharge ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 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. ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: June 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A: Apixaban Drug: Apixaban
Tablets, Oral, 5 mg, Once, 4 days
Other Name: Apixaban
Experimental: Group B: Apixaban Drug: Apixaban
Tablets, Oral, 5 mg, Twice, 15 days
Other Name: Apixaban

Detailed 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 .

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01340586

Locations
United States, Florida
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

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

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01340586     History of Changes
Other Study ID Numbers: CV185-087
Study First Received: April 21, 2011
Last Updated: November 29, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
PHARMACOKINETIC
NOS

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on May 19, 2013