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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 August 26, 2014