The purpose of this study is to evaluate the absorption of apixaban (BMS-562247) into the bloodstream of healthy volunteers, when administered as sprinkle capsules compared to tablets. Eligible participants will be randomly assigned to 1 of 2 treatment sequences and will receive a single oral dose of apixaban twice during the course of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
94
Single dose (25 x 0.1 mg capsules), oral administration
Apixaban sprinkle capsules Single dose (25 x 0.1 mg capsules), oral administration
PPD Development, LP
Austin, Texas, United States
Concentration as Measured by Maximum Observed Plasma Concentration (Cmax)
Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of concentration
Time frame: Day 1 to Day 8
AUC (0-T) - Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration
Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of plasma concentration and time
Time frame: Day 1 to Day 8
AUC (INF) - Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time
Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of plasma concentration and time
Time frame: Day 1 to Day 8
Tmax - Time of Maximum Observed Plasma Concentration
Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms time of maximum concentration
Time frame: Day 1 to Day 8
T-Half - Terminal Plasma Half Life.
Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of time required to reach to half of plasma concentration
Time frame: Day 1 to Day 8
Frel - Relative Bioavailability
The relative bioavailability of 0.1mg apixaban sprinkle capsules as compared to 0.5mg tablet formulation
Time frame: Day 1 to Day 8
Number of Participants With Adverse Events Regardless of Causality, Serious Adverse Events and Adverse Events Leading to Discontinuation
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Adverse events regardless of causality, Serious Adverse Events \& Adverse events leading to discontinuation
Time frame: Day 1 to Day 38
Physical Measurement - Height
Average height of all participants treated
Time frame: Pre-treatment Screening
Physical Measurement - Weight
Average weight of all participants treated
Time frame: Pre-treatment screening to Day 8
Physical Measurement - Body Mass Index (BMI)
Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive. Body mass index = weight (kg)/\[height(m)\]2.
Time frame: Pre-treatment Screening to Day 8
Number of Participants With a Given Clinical Laboratory Abnormality
Assessment of clinical laboratory abnormalities
Time frame: Day 1 to Day 8
Number of Participants With Out-of Range Vital Signs: Blood Pressure
Number of participants with Out-of Range Blood Pressure changes as follows: Systolic Blood Pressure (SBP) mmHg \< 90 and change from baseline \< -20 \> 140 and change from baseline \> 20 Diastolic Blood Pressure (DBP) mmHg \< 55 and change from baseline \< -10 \> 90 and change from baseline \> 10
Time frame: Day 1 to Day 8
Number of Participants With Out-of Range Vital Signs: Heart Rate (Bpm)
Number of participants with Out-of Range Heart Rate changes as follows: \< 55 and change from baseline \< -16 \>100 and change from baseline \> 10
Time frame: Day 1 to Day 8
Number of Participants With Out-of Range Vital Signs: Respiration Rate
Number of participants with Out-of Range respiration rate changes as follows: Respiration Rate is measured by number of respiration per min (rpm) \> 16 rpm Change from baseline \>10 rpm \> 16 rpm or change from baseline \> 10 rpm
Time frame: Day 1 to Day 8
Number of Participants With Out-of Range Vital Signs: Temperature
Number of participants with Out-of Range temperature changes as follows: Temperature is measured in Degrees centigrade (°C) \>38.3°C Change from baseline \> 1.6°C \>38.3°C or change from baseline \> 1.6°C
Time frame: Day 1 to Day 8
Number of Participants With Out-of Range ECG Evaluations
Number of participants with out-of-range ECG changes. ECG intervals are measured in milliseconds (msec)
Time frame: Day 1 to Day 8