Phase 1 Oral Solution and Crushed Tablet Relative Bioavailability Study of Apixaban When Administered Through a Nasogastric Tube in Healthy Subjects

Experimental: Arm A-Apixaban

Solution Apixaban 5 mg ( 0.4 mg/ml oral solution x 12.5 ml) through mouth or oral syringe

Droga: Apixabán

Otros nombres:

• BMS-562247

Experimental: Arm B-Apixaban

Oral Solution Apixaban 5 mg single dose (0.4 mg/mL oral solution x 12.5 mL) after 180 mL of Boost Plus®, followed by 60 mL of Boost Plus® via same NGT

Droga: Apixabán

Otros nombres:

• BMS-562247

Suplemento dietético: Boost Plus

Experimental: Arm C-Apixaban

Single dose crushed Apixaban tablet 5 mg (5 mg tablet crushed and suspended in 60 mL Dextrose 5% in water (D5W)) through NGT

Droga: Apixabán

Otros nombres:

• BMS-562247

Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban

Maximum observed plasma concentration (Cmax) is measured in nanograms per milliliter (ng/mL)

Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinite Time AUC(INF) of Apixaban

AUC(INF) is measured in nanogram hours per milliliter (ng*h/mL)

Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban

AUC(0-T) is measured in nanogram hours per milliliter (ng*h/mL)

Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban

Maximum observed plasma concentration (Cmax) is measured in nanograms per milliliter (ng/mL)

Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban

AUC(0-T) is measured in nanogram hours per milliliter (ng*h/mL)

Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Apixaban

AUC(INF) is measured in nanogram hours per milliliter (ng*h/mL)

Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths or Discontinuation of Study Drug Due to AEs

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. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0

Number of Participants With Marked Laboratory Abnormalities

Marked laboratory abnormalities were defined as laboratory assessments meeting the following investigator-specified criteria: Leukocytes >1.2* upper limits of normal (ULN) , Basophils >3%, Eosinophils >1.5*ULN, Blood Urine >=2, Red Blood Cell (RBC) Urine >=2, White Blood Cell (WBC) Urine >=2