Bioavailability of Apixaban Sprinkle Compared to Apixaban Capsules

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03509883
• Collaborator: (none)
• Enrollment: 94
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.6
• Patients Per Site Per Month: 57.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Drug: Apixaban sprinkle capsules; Drug: Experimental: Apixaban tablets followed by apixaban sprinkle capsules	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 94 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study to Assess the Absorption of Apixaban (BMS-562247) Sprinkle Capsules Compared With Tablets in Healthy Volunteers
• Actual Study Start Date: Apr 26, 2018
• Actual Primary Completion Date: Jun 15, 2018
• Actual Study Completion Date: Jun 15, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Apixaban sprinkle capsules followed by apixaban tablets Apixaban (BMS-562247) sprinkle capsules followed by apixaban tablets	Drug: Drug: Apixaban sprinkle capsules; Single dose (25 x 0.1 mg capsules), oral administration; Other Names: •BMS-562247 •Eliquis ; Drug: Experimental: Apixaban tablets followed by apixaban sprinkle capsules; Apixaban sprinkle capsules Single dose (25 x 0.1 mg capsules), oral administration; Other Names: •BMS-562247
Active Comparator: Apixaban tablets followed by apixaban sprinkle capsules Apixaban (BMS-562247) tablets followed by apixaban sprinkle capsules	Drug: Drug: Apixaban sprinkle capsules; Single dose (25 x 0.1 mg capsules), oral administration; Other Names: •BMS-562247 •Eliquis ; Drug: Experimental: Apixaban tablets followed by apixaban sprinkle capsules; Apixaban sprinkle capsules Single dose (25 x 0.1 mg capsules), oral administration; Other Names: •BMS-562247

Outcome Measures

Primary Outcome Measures

1. Concentration as Measured by Maximum Observed Plasma Concentration (Cmax) [Day 1 to Day 8]

   Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of concentration

2. AUC (0-T) - Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [Day 1 to Day 8]

   Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of plasma concentration and time

3. AUC (INF) - Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [Day 1 to Day 8]

   Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of plasma concentration and time

Secondary Outcome Measures

1. Tmax - Time of Maximum Observed Plasma Concentration [Day 1 to Day 8]

   Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms time of maximum concentration

2. T-Half - Terminal Plasma Half Life. [Day 1 to Day 8]

   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

3. Frel - Relative Bioavailability [Day 1 to Day 8]

   The relative bioavailability of 0.1mg apixaban sprinkle capsules as compared to 0.5mg tablet formulation

4. Number of Participants With Adverse Events Regardless of Causality, Serious Adverse Events and Adverse Events Leading to Discontinuation [Day 1 to Day 38]

   Adverse events regardless of causality, Serious Adverse Events & Adverse events leading to discontinuation

5. Physical Measurement - Height [Pre-treatment Screening]

   Average height of all participants treated

6. Physical Measurement - Weight [Pre-treatment screening to Day 8]

   Average weight of all participants treated

7. Physical Measurement - Body Mass Index (BMI) [Pre-treatment Screening to Day 8]

   Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive. Body mass index = weight (kg)/[height(m)]2.

8. Number of Participants With a Given Clinical Laboratory Abnormality [Day 1 to Day 8]

   Assessment of clinical laboratory abnormalities

9. Number of Participants With Out-of Range Vital Signs: Blood Pressure [Day 1 to Day 8]

   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

10. Number of Participants With Out-of Range Vital Signs: Heart Rate (Bpm) [Day 1 to Day 8]

    Number of participants with Out-of Range Heart Rate changes as follows: < 55 and change from baseline < -16 >100 and change from baseline > 10

11. Number of Participants With Out-of Range Vital Signs: Respiration Rate [Day 1 to Day 8]

    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

12. Number of Participants With Out-of Range Vital Signs: Temperature [Day 1 to Day 8]

    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

13. Number of Participants With Out-of Range ECG Evaluations [Day 1 to Day 8]

    Number of participants with out-of-range ECG changes. ECG intervals are measured in milliseconds (msec)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Signed informed consent form.

• Healthy male and female participants determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs (electrocardiograms), vital signs and clinical laboratory determinations.

• Women of childbearing potential (WOCBP) must have negative serum pregnancy tests (performed at screening and Day 1), must not be breastfeeding, and must agree to follow instructions for method(s) of contraception for duration of treatment with study drug apixaban, and for a total of 33 days after last dose of apixaban.

• Males sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for duration of treatment with study drug apixaban, and for a total of 93 days after the last dose of apixaban; and must be willing to refrain from sperm donation during this time.

• Body mass index (BMI) of 18.0 to 30.0 kg/m², inclusive. Body mass index = weight (kg)/[height(m)]².

Exclusion Criteria:

• History of chronic headaches (occurring 15 days or more a month) over the previous 3 months.

• History of gastroesophageal reflux disease, dyspepsia, protracted nausea, or chronic diarrhea.

• History or evidence of abnormal bleeding or coagulation disorders, hypermenorrhea, intracranial hemorrhage, or abnormal bleeding or coagulation disorders.

• Inability to comply with restrictions and prohibited treatments (e.g. women currently taking hormonal contraception).

• Use of tobacco- or nicotine-containing products (e.g. cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, nicotine gum) within 6 months prior to study drug administration.

• Donation of blood to a blood bank or in a clinical study (except screening or follow-up visit) within 4 weeks of study drug administration (within 2 weeks for plasma only).

Other protocol defined inclusion/exclusion criteria could apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PPD Development, LP	Austin	Texas	United States	78744

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Mar 21, 2018
• Statistical Analysis Plan - Jun 4, 2018

More Information

Additional Information:

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03509883
• Other Study ID Numbers: CV185-687
• First Posted: Apr 26, 2018
• Last Update Posted: Jan 23, 2020
• Last Verified: Jan 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Apixaban

Study Results

Participant Flow

Pre-assignment Detail	94 Participants Enrolled; 30 participants Randomized; Reasons Not Randomized: 43 participants no longer meet study criteria; 12 were lost to follow up 9 other; 5 screening extras: 4 back ups

Arm/Group Title	Treatment A, Then Treatment B	Treatment B, Then Treatment A
Arm/Group Description	Apixaban tablets (treatment A) followed by apixaban sprinkle capsules (treatment B)	Apixaban sprinkle capsules (treatment B) followed by apixaban tablets (treatment A)
Period Title: Initial Treatment
STARTED	15	15
COMPLETED	15	15
NOT COMPLETED	0	0
Period Title: Initial Treatment
STARTED	15	15
COMPLETED	15	15
NOT COMPLETED	0	0
Period Title: Initial Treatment
STARTED	15	15
COMPLETED	15	15
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Treatment A	Treatment B	Total
Arm/Group Description	Apixaban tablets (treatment A) followed by apixaban sprinkle capsules (treatment B)	Apixaban sprinkle capsules (treatment B) followed by apixaban tablets (treatment A)	Total of all reporting groups
Overall Participants	15	15	30
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	31.3 (7.6)	32.8 (7.3)	32.0 (7.4)
Sex: Female, Male (Count of Participants)
Female	8 53.3%	8 53.3%	16 53.3%
Male	7 46.7%	7 46.7%	14 46.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	6 40%	7 46.7%	13 43.3%
Not Hispanic or Latino	9 60%	8 53.3%	17 56.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 6.7%	1 3.3%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	5 33.3%	5 33.3%	10 33.3%
White	10 66.7%	9 60%	19 63.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Concentration as Measured by Maximum Observed Plasma Concentration (Cmax)
Description	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

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title	Treatment A	Treatment B
Arm/Group Description	Apixaban tablets (treatment A)	Apixaban sprinkle capsules (treatment B)
Measure Participants	30	30
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	77.4 (26.5)	99.3 (24.6)

2. Primary Outcome

Title	AUC (0-T) - Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration
Description	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

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title	Treatment A	Treatment B
Arm/Group Description	Apixaban tablets (treatment A)	Apixaban sprinkle capsules (treatment B)
Measure Participants	30	30
Geometric Mean (Geometric Coefficient of Variation) [ng*h/mL]	695.9 (27.3)	769.2 (23.7)

3. Primary Outcome

Title	AUC (INF) - Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time
Description	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

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title	Treatment A	Treatment B
Arm/Group Description	Apixaban tablets (treatment A)	Apixaban sprinkle capsules (treatment B)
Measure Participants	30	30
Geometric Mean (Geometric Coefficient of Variation) [ng*h/mL]	714.7 (26.9)	787.9 (23.1)

4. Secondary Outcome

Title	Tmax - Time of Maximum Observed Plasma Concentration
Description	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

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title	Treatment A	Treatment B
Arm/Group Description	Apixaban tablets (treatment A)	Apixaban sprinkle capsules (treatment B)
Measure Participants	30	30
Geometric Mean (Geometric Coefficient of Variation) [h (hours)]	2.30 (36.4)	0.98 (43.8)

5. Secondary Outcome

Title	T-Half - Terminal Plasma Half Life.
Description	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

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title	Treatment A	Treatment B
Arm/Group Description	Apixaban tablets (treatment A)	Apixaban sprinkle capsules (treatment B)
Measure Participants	30	30
Geometric Mean (Geometric Coefficient of Variation) [h (hours)]	8.81 (39.2)	7.91 (32.7)

6. Secondary Outcome

Title	Frel - Relative Bioavailability
Description	The relative bioavailability of 0.1mg apixaban sprinkle capsules as compared to 0.5mg tablet formulation
Time Frame	Day 1 to Day 8

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title	Treatment B
Arm/Group Description	Sprinkle Capsules as compared to tablet formulation
Measure Participants	30
Geometric Mean (Geometric Coefficient of Variation) [Percentage]	110.24 (9.3)

7. Secondary Outcome

Title	Number of Participants With Adverse Events Regardless of Causality, Serious Adverse Events and Adverse Events Leading to Discontinuation
Description	Adverse events regardless of causality, Serious Adverse Events & Adverse events leading to discontinuation
Time Frame	Day 1 to Day 38

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title	Treatment A	Treatment B
Arm/Group Description	Apixaban tablets (treatment A)	Apixaban sprinkle capsules (treatment B)
Measure Participants	30	30
Adverse Events	7 46.7%	3 20%
Serious Adverse Events	0 0%	0 0%
Adverse Events leading to Discontinuation	0 0%	0 0%

8. Secondary Outcome

Title	Physical Measurement - Height
Description	Average height of all participants treated
Time Frame	Pre-treatment Screening

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Treatment A	Treatment B
Arm/Group Description	Apixaban tablets (treatment A)	Apixaban sprinkle capsules (treatment B)
Measure Participants	30	30
Mean (Standard Deviation) [centimeter (cm)]	173.23 (5.81)	165.86 (8.86)

9. Secondary Outcome

Title	Physical Measurement - Weight
Description	Average weight of all participants treated
Time Frame	Pre-treatment screening to Day 8

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Treatment A	Treatment B
Arm/Group Description	Apixaban tablets (treatment A)	Apixaban sprinkle capsules (treatment B)
Measure Participants	30	30
Pre-treatment	78.09 (5.81)	165.86 (8.86)
Day 1	77.83 (3.35)	71.47 (12.55)
Day 8	76.15 (11.60)	70.64 (12.28)

10. Secondary Outcome

Title	Physical Measurement - Body Mass Index (BMI)
Description	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

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Treatment A	Treatment B
Arm/Group Description	Apixaban tablets (treatment A)	Apixaban sprinkle capsules (treatment B)
Measure Participants	30	30
Pre-treatment	22.96 (3.35)	25.85 (2.91)
Day 1	25.87 (3.50)	25.84 (2.87)
Day 8	25.31 (3.25)	25.55 (2.79)

11. Secondary Outcome

Title	Number of Participants With a Given Clinical Laboratory Abnormality
Description	Assessment of clinical laboratory abnormalities
Time Frame	Day 1 to Day 8

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title	Treatment A	Treatment B
Arm/Group Description	Apixaban tablets (treatment A)	Apixaban sprinkle capsules (treatment B)
Measure Participants	30	30
hemoglobin abnormal low	0 0%	0 0%
Hematocrit abnormal low	0 0%	0 0%
Platelet count abnormal low	0 0%	0 0%
platelet count abnormal high	0 0%	0 0%
Leukocytes abnormal low	0 0%	0 0%
Leukocytes Abnormal high	0 0%	0 0%
Neutrophils (Absolute) Abnormal low	2 13.3%	1 6.7%
Lymphocytes abnormal low	0 0%	0 0%
Lymphocytes Abnormal high	0 0%	0 0%
Monocytes (Absolute) Abnormal High	0 0%	0 0%
Basophils (absolute) Abnormal High	0 0%	0 0%
Eosinophils (absolute) Abnormal High	0 0%	0 0%
Prothrombin Time (PT) Abnormal High	0 0%	0 0%
International Normalized Ratio (INR) Abnormal High	0 0%	0 0%
Alkaline Phosphate (ALP) Abnormal High	0 0%	0 0%
Aspartate Aminotransferase (AST) Abnormal High	0 0%	0 0%
Alanine Aminotransferase (ALT) Abnormal High	0 0%	0 0%
Bilirubin, Total Abnormal High	0 0%	0 0%
Blood Urea Nitrogen (BUN) Abnormal High	0 0%	0 0%
Creatinine Abnormal High	0 0%	0 0%
Sodium Abnormal Low	0 0%	0 0%
Sodium, Serum Abnormal High	0 0%	0 0%
Potassium Abnormal Low	0 0%	0 0%
Potassium, Serum Abnormal High	0 0%	0 0%
Chloride, Serum Abnormal Low	0 0%	0 0%
Chloride, Serum Abnormal High	0 0%	0 0%
Calcium, Serum Abnormal Low	0 0%	0 0%
Calcium, Serum Abnormal High	0 0%	0 0%
Phosphorus, Inorganic Abnormal Low	0 0%	0 0%
Phosphorus, Inorganic Abnormal High	0 0%	0 0%
Glucose, Fasting Serum Abnormal Low	0 0%	0 0%
Glucose, Fasting Serum Abnormal High	0 0%	0 0%
Protein, Total Abnormal Low	0 0%	0 0%
Protein, Total Abnormal High	0 0%	0 0%
Albumin Abnormal Low	0 0%	0 0%
Lactate Dehydrogenase (LDH) Abnormal High	0 0%	0 0%
Protein, Urine Abnormal High	0 0%	0 0%
Glucose, Urine Abnormal High	0 0%	0 0%
Blood, Urine Abnormal High	2 13.3%	2 13.3%
WBC, Urine Abnormal High	2 13.3%	2 13.3%
RBC, Urine Abnormal High	1 6.7%	0 0%

12. Secondary Outcome

Title	Number of Participants With Out-of Range Vital Signs: Blood Pressure
Description	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

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Treatment A	Treatment B
Arm/Group Description	Apixaban tablets (treatment A)	Apixaban sprinkle capsules (treatment B)
Measure Participants	30	30
SBP < 90 and change from baseline < -20	0 0%	0 0%
SBP >140 and change from baseline >20	0 0%	0 0%
DBP < 55 and change from baseline < -10	0 0%	1 6.7%
DBP >90 and change from baseline >10	0 0%	0 0%

13. Secondary Outcome

Title	Number of Participants With Out-of Range Vital Signs: Heart Rate (Bpm)
Description	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

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Treatment A	Treatment B
Arm/Group Description	Apixaban tablets (treatment A)	Apixaban sprinkle capsules (treatment B)
Measure Participants	30	30
<55 and change from baseline < -16	0 0%	0 0%
>100 and change from baseline > 10	0 0%	0 0%

14. Secondary Outcome

Title	Number of Participants With Out-of Range Vital Signs: Respiration Rate
Description	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

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Treatment A	Treatment B
Arm/Group Description	Apixaban tablets (treatment A)	Apixaban sprinkle capsules (treatment B)
Measure Participants	30	30
>16 rpm	1 6.7%	1 6.7%
change from baseline > 10 rpm	0 0%	0 0%
>16 or change from baseline >10 rpm	1 6.7%	1 6.7%

15. Secondary Outcome

Title	Number of Participants With Out-of Range Vital Signs: Temperature
Description	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

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Treatment A	Treatment B
Arm/Group Description	Apixaban tablets (treatment A)	Apixaban sprinkle capsules (treatment B)
Measure Participants	30	30
>38.3°C	0 0%	0 0%
change from baseline > 1.6°C	0 0%	0 0%
>38.3°C or change from baseline > 1.6°C	0 0%	0 0%

16. Secondary Outcome

Title	Number of Participants With Out-of Range ECG Evaluations
Description	Number of participants with out-of-range ECG changes. ECG intervals are measured in milliseconds (msec)
Time Frame	Day 1 to Day 8

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Treatment A	Treatment B
Arm/Group Description	Apixaban tablets (treatment A)	Apixaban sprinkle capsules (treatment B)
Measure Participants	30	30
PR Interval Baseline ≤ 200	30 200%	30 200%
PR Interval Baseline >200	0 0%	0 0%
PR Interval Maximum on Treatment ≤ 200	29 193.3%	30 200%
PR Interval Maximum on Treatment >200	1 6.7%	0 0%
QRS Interval Baseline ≤ 120	30 200%	30 200%
QRS Interval Baseline >200	0 0%	0 0%
QRS Interval Maximum on Treatment ≤ 120	30 200%	30 200%
QRS Interval Maximum on Treatment > 120	0 0%	0 0%
QT Interval Baseline ≤ 500	30 200%	30 200%
QT Interval Baseline >500	0 0%	0 0%
QT Interval Maximum on Treatment ≤ 500	30 200%	30 200%
QT Interval Maximum on Treatment > 500	0 0%	0 0%
QT Interval Increase from Baseline ≤ 30	29 193.3%	29 193.3%
QT Interval Increase from Baseline > 30	1 6.7%	1 6.7%
QTcF Interval Baseline ≤ 450	30 200%	30 200%
QTcF Interval Baseline >450	0 0%	0 0%
QTcF Interval Maximum on Treatment ≤ 450	30 200%	30 200%
QTcF Interval Maximum on Treatment > 450	0 0%	0 0%
QTcF Interval Increase from Baseline ≤ 30	30 200%	30 200%
QTcF Interval Increase from Baseline > 30	0 0%	0 0%

Adverse Events

Time Frame	40 days (1st dose to 30 days after study completion)
Arm/Group Title	Treatment A		Treatment B
Arm/Group Description	Apixaban tablets 5 × 0.5-mg		Apixaban sprinkle capsules (treatment B)
All Cause Mortality
	Treatment A		Treatment B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Serious Adverse Events
	Treatment A		Treatment B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Treatment A		Treatment B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/30 (6.7%)		0/30 (0%)
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain	2/30 (6.7%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.