Logo 1 Logo 2

Clinical Trial Details

Trial ID: L0917
Source ID: NCT01340586
Associated Drug: Apixaban
Title: Pharmacokinetics and Pharmacodynamics of Apixaban in Subjects on Hemodialysis
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01340586/results
Conditions: End Stage Renal Disease
Interventions: DRUG: Apixaban|DRUG: Apixaban
Outcome Measures: Primary: Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Single 5mg Oral Dose of Apixaban, Maximum observed plasma concentration (Cmax) was measured by plasma concentration of apixaban over time. The geometric means are reported in nanograms per milliliter (ng/mL)., 24 hours pre-dose to 72 hours post-dose|Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Metabolite BMS-730823, Maximum observed plasma concentration (Cmax) was measured by plasma concentration of BMS-730823 over time. The geometric means are reported in nanograms per milliliter (ng/mL)., From 24 hours pre-dose to 72 hours post-dose|Geometric Mean of Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T)) of Single 5mg Oral Dose of Apixaban, Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of apixaban over time. The geometric means are reported in nanogram hours per milliliter (ng\*h/mL)., 24 hours pre-dose to 72 hours post-dose|Geometric Mean of Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T)) of Metabolite BMS-730823, Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of BMS-730823 over time. The geometric means are reported in nanogram hours per milliliter (ng\*h/mL)., From 24 hours pre-dose to 72 hours post-dose|Geometric Mean of Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of Single 5mg Oral Dose of Apixaban, The area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was measured by plasma concentration of apixaban over time. The geometric means are reported in nanogram hours per milliliter (ng\*h/mL)., From 24 hours pre-dose to 72 hours post-dose|Geometric Mean of Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-730823, The area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was measured by plasma concentration of BMS-730823 over time. The geometric means are reported in nanogram hours per milliliter (ng\*h/mL)., 24 hours pre-dose to 72 hours post-dose|Mean Plasma Terminal Half-life (T-Half) of Single 5mg Oral Dose of Apixaban, Plasma terminal half-life (T-Half) for apixaban was derived from plasma concentrations versus time data. Means were reported in hours., From 24 hours pre-dose to 72 hours post-dose|Mean Plasma Terminal Half-life (T-Half) of BMS-730823, Mean plasma terminal half-life (T-Half) for BMS-730823 was derived from plasma concentrations versus time data., 24 hours pre-dose to 72 hours post-dose|Median Time of Maximum Observed Plasma Concentration (Tmax) of a Single 5 mg Oral Dose of Apixaban, Time of maximum observed plasma concentration (Tmax) for apixaban was derived from plasma concentrations versus time data. Medians were reported in hours., From 24 hours pre-dose to 72 hours post-dose|Median Time of Maximum Observed Plasma Concentration (Tmax) of Metabolite BMS-730823, Time of maximum observed plasma concentration (Tmax) for BMS-730823 was derived from plasma concentrations versus time data. Medians were reported in hours., From 24 hours pre-dose to 72 hours post-dose|Geometric Mean of Area Under the Plasma Concentration-Time Curve From 2 to 6 Hours (AUC(2-6)) for Apixaban, Area under the plasma concentration-time curve from 2 hours to 6 hours (AUC(2-6) for Apixaban was measured in participants with ESRD during dialysis in Period 1 only. Geometric Means were reported in nanogram hours per milliliter (ng\*hr/mL) and were determined from blood samples both entering and exiting the dialyzer., 2 to 6 hours post-dose|Geometric Mean of Area Under the Plasma Concentration-Time Curve From 2 to 6 Hours (AUC(2-6)) for BMS-730823, Area under the plasma concentration-time curve from 2 hours to 6 hours (AUC(2-6) for BMS-730823 was measured in participants with ESRD during dialysis in Period 1 only. Geometric Means were reported in nanogram hours per milliliter (ng\*hr/mL) and were determined from blood samples both entering and exiting the dialyzer., 2 to 6 hours post-dose|Mean Percent Dose of Apixaban Recovered in Urine (%UR), The percent dose recovered in urine was calculated by dividing the cumulative amount of unchanged apixaban excreted in urine from the time of dose up to 72 hours post-dose by the apixaban dose administered., 24 hours pre-dose to 72 hours post-dose|Mean Percent Dose of Apixaban Recovered in Dialysate (%DR), Percent dose of Apixaban recovered in dialysate (%DR) was calculated by dividing the cumulative amount of apixaban excreted in each dialysate collection over 2-6 hours (DR(2-6)) by the apixaban dose. %DR was recorded only in period 1., 2 to 6 hours post-dose|Mean Renal Clearance (CLR) of Apixaban, Renal clearance (CLR) was calculated by dividing the cumulative amount of apixaban excreted in urine by the respective cumulative plasma AUC over the same urine collection interval. Geometric means were reported in milliliters per minute (mL/min)., 24 hours pre-dose to 72 hours post-dose|Mean Renal Clearance (CLR) of BMS-730823, Renal clearance (CLR) was calculated by dividing the cumulative amount of BMS-730823 excreted in urine by the respective cumulative plasma AUC over the same urine collection interval. Geometric means were reported in milliliters per minute (mL/min)., 24 hours pre-dose to 72 hours post-dose|Mean Hemodialysis Clearance (CLD) of Apixaban, Hemodialysis clearance (CLD) was calculated by dividing the cumulative amount of apixaban excreted in dialysate by the respective cumulative plasma AUC over the same dialysate collection interval (AUC(2-6) entering). CLD measurements occurred only in period 1. Geometric means were reported in milliliters per minute (mL/min)., 2 to 6 hours post-dose|Mean Hemodialysis Clearance (CLD) of BMS-730823, Hemodialysis clearance (CLD) was calculated by dividing the cumulative amount of BMS-730823 excreted in dialysate by the respective cumulative plasma AUC over the same dialysate collection interval (AUC(2-6) entering). CLD measurements occurred only in period 1. Geometric means were reported in milliliters per minute (mL/min)., 2 to 6 hours post-dose|Percentage of Apixaban Extracted During Hemodialysis, The percentage of apixaban extracted during hemodialysis (extraction ratio) was calculated using the formula \[plasma AUC(2-6) exiting - AUC(2-6) entering\] / \[AUC(2-6) entering\] and converted to a percentage. The extraction ratio was measured in period 1 only, and was reported as a percentage., 2 to 6 hours post-dose|Percentage of BMS-730823 Extracted During Hemodialysis, The percentage of BMS-730823 extracted during hemodialysis (extraction ratio) was calculated using the formula \[plasma AUC(2-6)exiting - AUC(2-6)entering\] / \[AUC(2-6) entering\] and converted to a percentage. The extraction ratio was measured in period 1 only, and was reported as a percentage., 2 to 6 hours post-dose | Secondary: Mean Maximum Percent Change From Baseline International Normalized Ratio (INR) Following a Single 5 mg Oral Dose of Apixaban, The mean maximum percent change in baseline for INR was reported for each arm. Baseline measurements were assessed up to 24 hours prior to Day 1 dosing., From 24 hours pre-dose to 72 hours post-dose|Mean Maximum Percent Change From Baseline Prothrombin Time (PT) Following a Single 5 mg Oral Dose of Apixaban, The mean maximum percent change in Prothrombin Time (PT) from baseline was reported for all treated participants. Baseline measurements were assessed up to 24 hours prior to Day 1 dosing., From 24 hours pre-dose to 72 hours post-dose|Mean Maximum Percent Change From Baseline Activated Partial Thromboplastin Time (aPTT) Following a Single Oral Dose of 5 mg Apixaban, The mean maximum percent change in Activated Partial Thromboplastin Time (aPTT) from baseline was reported for all treated participants. Baseline measurements were assessed up to 24 hours prior to Day 1 dosing., From 24 hours pre-dose to 72 hours post-dose|Mean Peak Anti-FXa Activity Following a Single Oral Dose of 5 mg Apixaban, Anti-FXa activity was assessed from an activity-time profile for doses both before and after hemodialysis. Maximal means were reported in International Units per milliliter (IU/mL)., From 24 hours pre-dose to 72 hours post-dose | Other: Number of Participants With Laboratory Marked Abnormalities, ULN=Upper Limit of Normal, LLN=Lower Limit of Normal, Pre-Rx= Baseline value. BUN=Blood Urea Nitrogen (mmol/L=millimoles per Liter): High if BUN \> 1.1\*ULN (if Pre-Rx\>ULN: \>1.25\*Pre-Rx). Platelet count (\*10\^9 cell/L): Low if Platelet Count \< 0.85\*LLN (if Pre-Rx\<LLN: \<0.85\*Pre-Rx). Creatine (umol/L=micromoles per Liter): High if Creatine \> 1.5\*ULN (if Pre-Rx\>ULN: \>1.33\*Pre-Rx). Calcium, Total (mmol/L): High if Calcium \> 1.5\*ULN (if Pre-Rx\>ULN: \>1.33\*Pre-Rx). Potassium, serum (mmol/L): High if Potassium \> 1.1\*ULN (if Pre-Rx\>ULN: \>1.1\*Pre-Rx; if Pre-Rx\<LLN: \>ULN). Phosphorus, Inorganic (mmol/L): Low if Phosphate \< 0.85\*LLN (if Pre-Rx\>ULN: \<LLN). Lactate dehydrogenase (U/L=Units per Liter): High if Lactate Dehydrogenase \> 1.25\*ULN (if Pre-Rx\>ULN: \>1.5\*Pre-Rx)., From 24 hours pre-dose to 72 hours post-dose|Number of Participants Who Died or Experienced Serious Adverse Events (SAEs) or Adverse Events Leading to Discontinuation, The number of participants who died or experienced SAEs or AEs leading to discontinuation was reported for each arm. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling., From Day 1 to 30 days post study discontinuation
Sponsor/Collaborators: Sponsor: Bristol-Myers Squibb
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 18
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose:
Start Date: 2011-06
Completion Date: 2011-09
Results First Posted: 2016-10-11
Last Update Posted: 2016-10-11
Locations: Orlando, Florida, United States
URL: https://clinicaltrials.gov/show/NCT01340586