Pharmacokinetics and Pharmacodynamics of Apixaban in Subjects on Hemodialysis | RxWiki

Pharmacokinetics and Pharmacodynamics of Apixaban in Subjects on Hemodialysis

Overview[ - collapse ][ - ]

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	End Stage Renal Disease
Intervention	Drug: Apixaban Drug: Apixaban
Phase	Phase 1
Sponsor	Bristol-Myers Squibb
Responsible Party	Bristol-Myers Squibb
ClinicalTrials.gov Identifier	NCT01340586
First Received	April 21, 2011
Last Updated	November 29, 2011
Last verified	July 2011

Tracking Information[ + expand ][ + ]

First Received Date	April 21, 2011
Last Updated Date	November 29, 2011
Start Date	June 2011
Estimated Primary Completion Date	September 2011
Current 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]
Current 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]

Descriptive Information[ + expand ][ + ]

Brief Title	Pharmacokinetics and Pharmacodynamics of Apixaban in Subjects on Hemodialysis
Official Title	Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Apixaban in Subjects on Hemodialysis
Brief 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.
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 .
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label
Condition	End Stage Renal Disease
Intervention	Drug: Apixaban Tablets, Oral, 5 mg, Once, 4 days Other Names: ApixabanDrug: Apixaban Tablets, Oral, 5 mg, Twice, 15 days Other Names: Apixaban
Study Arm (s)	Experimental: Group A: Apixaban Experimental: Group B: Apixaban

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	16
Estimated Completion Date	September 2011
Estimated Primary Completion Date	September 2011
Eligibility 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.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01340586
Other Study ID Numbers	CV185-087
Has Data Monitoring Committee	No
Information Provided By	Bristol-Myers Squibb
Study Sponsor	Bristol-Myers Squibb
Collaborators	Not Provided
Investigators	Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Verification Date	July 2011

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