Trial Outcomes & Findings for Bioavailability of Apixaban Sprinkle Compared to Apixaban Capsules (NCT NCT03509883)
NCT ID: NCT03509883
Last Updated: 2020-01-23
Results Overview
Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of concentration
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
94 participants
Primary outcome timeframe
Day 1 to Day 8
Results posted on
2020-01-23
Participant Flow
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
Participant milestones
| Measure |
Treatment A, Then Treatment B
Apixaban tablets (treatment A) followed by apixaban sprinkle capsules (treatment B)
|
Treatment B, Then Treatment A
Apixaban sprinkle capsules (treatment B) followed by apixaban tablets (treatment A)
|
|---|---|---|
|
Initial Treatment
STARTED
|
15
|
15
|
|
Initial Treatment
COMPLETED
|
15
|
15
|
|
Initial Treatment
NOT COMPLETED
|
0
|
0
|
|
Initial Treatment Washout
STARTED
|
15
|
15
|
|
Initial Treatment Washout
COMPLETED
|
15
|
15
|
|
Initial Treatment Washout
NOT COMPLETED
|
0
|
0
|
|
Cross-over and Treatment
STARTED
|
15
|
15
|
|
Cross-over and Treatment
COMPLETED
|
15
|
15
|
|
Cross-over and Treatment
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bioavailability of Apixaban Sprinkle Compared to Apixaban Capsules
Baseline characteristics by cohort
| Measure |
Treatment A
n=15 Participants
Apixaban tablets (treatment A) followed by apixaban sprinkle capsules (treatment B)
|
Treatment B
n=15 Participants
Apixaban sprinkle capsules (treatment B) followed by apixaban tablets (treatment A)
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.3 Years
STANDARD_DEVIATION 7.6 • n=99 Participants
|
32.8 Years
STANDARD_DEVIATION 7.3 • n=107 Participants
|
32.0 Years
STANDARD_DEVIATION 7.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 8Population: All Treated Participants
Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of concentration
Outcome measures
| Measure |
Treatment A
n=30 Participants
Apixaban tablets (treatment A)
|
Treatment B
n=30 Participants
Apixaban sprinkle capsules (treatment B)
|
|---|---|---|
|
Concentration as Measured by Maximum Observed Plasma Concentration (Cmax)
|
77.4 ng/mL
Geometric Coefficient of Variation 26.5
|
99.3 ng/mL
Geometric Coefficient of Variation 24.6
|
PRIMARY outcome
Timeframe: Day 1 to Day 8Population: All Treated Participants
Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of plasma concentration and time
Outcome measures
| Measure |
Treatment A
n=30 Participants
Apixaban tablets (treatment A)
|
Treatment B
n=30 Participants
Apixaban sprinkle capsules (treatment B)
|
|---|---|---|
|
AUC (0-T) - Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration
|
695.9 ng*h/mL
Geometric Coefficient of Variation 27.3
|
769.2 ng*h/mL
Geometric Coefficient of Variation 23.7
|
PRIMARY outcome
Timeframe: Day 1 to Day 8Population: All Treated Participants
Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of plasma concentration and time
Outcome measures
| Measure |
Treatment A
n=30 Participants
Apixaban tablets (treatment A)
|
Treatment B
n=30 Participants
Apixaban sprinkle capsules (treatment B)
|
|---|---|---|
|
AUC (INF) - Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time
|
714.7 ng*h/mL
Geometric Coefficient of Variation 26.9
|
787.9 ng*h/mL
Geometric Coefficient of Variation 23.1
|
SECONDARY outcome
Timeframe: Day 1 to Day 8Population: All Treated Participants
Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms time of maximum concentration
Outcome measures
| Measure |
Treatment A
n=30 Participants
Apixaban tablets (treatment A)
|
Treatment B
n=30 Participants
Apixaban sprinkle capsules (treatment B)
|
|---|---|---|
|
Tmax - Time of Maximum Observed Plasma Concentration
|
2.30 h (hours)
Geometric Coefficient of Variation 36.4
|
0.98 h (hours)
Geometric Coefficient of Variation 43.8
|
SECONDARY outcome
Timeframe: Day 1 to Day 8Population: All Treated Participants
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
Outcome measures
| Measure |
Treatment A
n=30 Participants
Apixaban tablets (treatment A)
|
Treatment B
n=30 Participants
Apixaban sprinkle capsules (treatment B)
|
|---|---|---|
|
T-Half - Terminal Plasma Half Life.
|
8.81 h (hours)
Geometric Coefficient of Variation 39.2
|
7.91 h (hours)
Geometric Coefficient of Variation 32.7
|
SECONDARY outcome
Timeframe: Day 1 to Day 8Population: All Treated Participants
The relative bioavailability of 0.1mg apixaban sprinkle capsules as compared to 0.5mg tablet formulation
Outcome measures
| Measure |
Treatment A
n=30 Participants
Apixaban tablets (treatment A)
|
Treatment B
Apixaban sprinkle capsules (treatment B)
|
|---|---|---|
|
Frel - Relative Bioavailability
|
110.24 Percentage
Geometric Coefficient of Variation 9.3
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 38Population: All Treated Participants
Adverse events regardless of causality, Serious Adverse Events \& Adverse events leading to discontinuation
Outcome measures
| Measure |
Treatment A
n=30 Participants
Apixaban tablets (treatment A)
|
Treatment B
n=30 Participants
Apixaban sprinkle capsules (treatment B)
|
|---|---|---|
|
Number of Participants With Adverse Events Regardless of Causality, Serious Adverse Events and Adverse Events Leading to Discontinuation
Adverse Events
|
7 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events Regardless of Causality, Serious Adverse Events and Adverse Events Leading to Discontinuation
Serious Adverse Events
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Regardless of Causality, Serious Adverse Events and Adverse Events Leading to Discontinuation
Adverse Events leading to Discontinuation
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-treatment ScreeningPopulation: All treated participants
Average height of all participants treated
Outcome measures
| Measure |
Treatment A
n=30 Participants
Apixaban tablets (treatment A)
|
Treatment B
n=30 Participants
Apixaban sprinkle capsules (treatment B)
|
|---|---|---|
|
Physical Measurement - Height
|
173.23 centimeter (cm)
Standard Deviation 5.81
|
165.86 centimeter (cm)
Standard Deviation 8.86
|
SECONDARY outcome
Timeframe: Pre-treatment screening to Day 8Population: All treated participants
Average weight of all participants treated
Outcome measures
| Measure |
Treatment A
n=30 Participants
Apixaban tablets (treatment A)
|
Treatment B
n=30 Participants
Apixaban sprinkle capsules (treatment B)
|
|---|---|---|
|
Physical Measurement - Weight
Pre-treatment
|
78.09 kilograms (kg)
Standard Deviation 5.81
|
165.86 kilograms (kg)
Standard Deviation 8.86
|
|
Physical Measurement - Weight
Day 1
|
77.83 kilograms (kg)
Standard Deviation 3.35
|
71.47 kilograms (kg)
Standard Deviation 12.55
|
|
Physical Measurement - Weight
Day 8
|
76.15 kilograms (kg)
Standard Deviation 11.60
|
70.64 kilograms (kg)
Standard Deviation 12.28
|
SECONDARY outcome
Timeframe: Pre-treatment Screening to Day 8Population: All treated participants
Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive. Body mass index = weight (kg)/\[height(m)\]2.
Outcome measures
| Measure |
Treatment A
n=30 Participants
Apixaban tablets (treatment A)
|
Treatment B
n=30 Participants
Apixaban sprinkle capsules (treatment B)
|
|---|---|---|
|
Physical Measurement - Body Mass Index (BMI)
Pre-treatment
|
22.96 kilograms / Meters² (kg/m²)
Standard Deviation 3.35
|
25.85 kilograms / Meters² (kg/m²)
Standard Deviation 2.91
|
|
Physical Measurement - Body Mass Index (BMI)
Day 1
|
25.87 kilograms / Meters² (kg/m²)
Standard Deviation 3.50
|
25.84 kilograms / Meters² (kg/m²)
Standard Deviation 2.87
|
|
Physical Measurement - Body Mass Index (BMI)
Day 8
|
25.31 kilograms / Meters² (kg/m²)
Standard Deviation 3.25
|
25.55 kilograms / Meters² (kg/m²)
Standard Deviation 2.79
|
SECONDARY outcome
Timeframe: Day 1 to Day 8Population: All Treated Participants
Assessment of clinical laboratory abnormalities
Outcome measures
| Measure |
Treatment A
n=30 Participants
Apixaban tablets (treatment A)
|
Treatment B
n=30 Participants
Apixaban sprinkle capsules (treatment B)
|
|---|---|---|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Blood Urea Nitrogen (BUN) Abnormal High
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
hemoglobin abnormal low
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Hematocrit abnormal low
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Platelet count abnormal low
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
platelet count abnormal high
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Leukocytes abnormal low
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Leukocytes Abnormal high
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Neutrophils (Absolute) Abnormal low
|
2 participants
|
1 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Lymphocytes abnormal low
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Lymphocytes Abnormal high
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Monocytes (Absolute) Abnormal High
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Basophils (absolute) Abnormal High
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Eosinophils (absolute) Abnormal High
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Prothrombin Time (PT) Abnormal High
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
International Normalized Ratio (INR) Abnormal High
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Alkaline Phosphate (ALP) Abnormal High
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Aspartate Aminotransferase (AST) Abnormal High
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Alanine Aminotransferase (ALT) Abnormal High
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Bilirubin, Total Abnormal High
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Creatinine Abnormal High
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Sodium Abnormal Low
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Sodium, Serum Abnormal High
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Potassium Abnormal Low
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Potassium, Serum Abnormal High
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Chloride, Serum Abnormal Low
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Chloride, Serum Abnormal High
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Calcium, Serum Abnormal Low
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Calcium, Serum Abnormal High
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Phosphorus, Inorganic Abnormal Low
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Phosphorus, Inorganic Abnormal High
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Glucose, Fasting Serum Abnormal Low
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Glucose, Fasting Serum Abnormal High
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Protein, Total Abnormal Low
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Protein, Total Abnormal High
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Albumin Abnormal Low
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Lactate Dehydrogenase (LDH) Abnormal High
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Protein, Urine Abnormal High
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Glucose, Urine Abnormal High
|
0 participants
|
0 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
Blood, Urine Abnormal High
|
2 participants
|
2 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
WBC, Urine Abnormal High
|
2 participants
|
2 participants
|
|
Number of Participants With a Given Clinical Laboratory Abnormality
RBC, Urine Abnormal High
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 8Population: All treated participants
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
Outcome measures
| Measure |
Treatment A
n=30 Participants
Apixaban tablets (treatment A)
|
Treatment B
n=30 Participants
Apixaban sprinkle capsules (treatment B)
|
|---|---|---|
|
Number of Participants With Out-of Range Vital Signs: Blood Pressure
SBP < 90 and change from baseline < -20
|
0 participants
|
0 participants
|
|
Number of Participants With Out-of Range Vital Signs: Blood Pressure
SBP >140 and change from baseline >20
|
0 participants
|
0 participants
|
|
Number of Participants With Out-of Range Vital Signs: Blood Pressure
DBP < 55 and change from baseline < -10
|
0 participants
|
1 participants
|
|
Number of Participants With Out-of Range Vital Signs: Blood Pressure
DBP >90 and change from baseline >10
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 8Population: All treated participants
Number of participants with Out-of Range Heart Rate changes as follows: \< 55 and change from baseline \< -16 \>100 and change from baseline \> 10
Outcome measures
| Measure |
Treatment A
n=30 Participants
Apixaban tablets (treatment A)
|
Treatment B
n=30 Participants
Apixaban sprinkle capsules (treatment B)
|
|---|---|---|
|
Number of Participants With Out-of Range Vital Signs: Heart Rate (Bpm)
<55 and change from baseline < -16
|
0 participants
|
0 participants
|
|
Number of Participants With Out-of Range Vital Signs: Heart Rate (Bpm)
>100 and change from baseline > 10
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 8Population: All treated participants
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
Outcome measures
| Measure |
Treatment A
n=30 Participants
Apixaban tablets (treatment A)
|
Treatment B
n=30 Participants
Apixaban sprinkle capsules (treatment B)
|
|---|---|---|
|
Number of Participants With Out-of Range Vital Signs: Respiration Rate
>16 rpm
|
1 participants
|
1 participants
|
|
Number of Participants With Out-of Range Vital Signs: Respiration Rate
change from baseline > 10 rpm
|
0 participants
|
0 participants
|
|
Number of Participants With Out-of Range Vital Signs: Respiration Rate
>16 or change from baseline >10 rpm
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 8Population: All treated participants
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
Outcome measures
| Measure |
Treatment A
n=30 Participants
Apixaban tablets (treatment A)
|
Treatment B
n=30 Participants
Apixaban sprinkle capsules (treatment B)
|
|---|---|---|
|
Number of Participants With Out-of Range Vital Signs: Temperature
>38.3°C
|
0 participants
|
0 participants
|
|
Number of Participants With Out-of Range Vital Signs: Temperature
change from baseline > 1.6°C
|
0 participants
|
0 participants
|
|
Number of Participants With Out-of Range Vital Signs: Temperature
>38.3°C or change from baseline > 1.6°C
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 8Population: All treated participants
Number of participants with out-of-range ECG changes. ECG intervals are measured in milliseconds (msec)
Outcome measures
| Measure |
Treatment A
n=30 Participants
Apixaban tablets (treatment A)
|
Treatment B
n=30 Participants
Apixaban sprinkle capsules (treatment B)
|
|---|---|---|
|
Number of Participants With Out-of Range ECG Evaluations
QT Interval Baseline ≤ 500
|
30 participants
|
30 participants
|
|
Number of Participants With Out-of Range ECG Evaluations
PR Interval Baseline ≤ 200
|
30 participants
|
30 participants
|
|
Number of Participants With Out-of Range ECG Evaluations
PR Interval Baseline >200
|
0 participants
|
0 participants
|
|
Number of Participants With Out-of Range ECG Evaluations
PR Interval Maximum on Treatment ≤ 200
|
29 participants
|
30 participants
|
|
Number of Participants With Out-of Range ECG Evaluations
PR Interval Maximum on Treatment >200
|
1 participants
|
0 participants
|
|
Number of Participants With Out-of Range ECG Evaluations
QRS Interval Baseline ≤ 120
|
30 participants
|
30 participants
|
|
Number of Participants With Out-of Range ECG Evaluations
QRS Interval Baseline >200
|
0 participants
|
0 participants
|
|
Number of Participants With Out-of Range ECG Evaluations
QRS Interval Maximum on Treatment ≤ 120
|
30 participants
|
30 participants
|
|
Number of Participants With Out-of Range ECG Evaluations
QRS Interval Maximum on Treatment > 120
|
0 participants
|
0 participants
|
|
Number of Participants With Out-of Range ECG Evaluations
QT Interval Baseline >500
|
0 participants
|
0 participants
|
|
Number of Participants With Out-of Range ECG Evaluations
QT Interval Maximum on Treatment ≤ 500
|
30 participants
|
30 participants
|
|
Number of Participants With Out-of Range ECG Evaluations
QT Interval Maximum on Treatment > 500
|
0 participants
|
0 participants
|
|
Number of Participants With Out-of Range ECG Evaluations
QT Interval Increase from Baseline ≤ 30
|
29 participants
|
29 participants
|
|
Number of Participants With Out-of Range ECG Evaluations
QT Interval Increase from Baseline > 30
|
1 participants
|
1 participants
|
|
Number of Participants With Out-of Range ECG Evaluations
QTcF Interval Baseline ≤ 450
|
30 participants
|
30 participants
|
|
Number of Participants With Out-of Range ECG Evaluations
QTcF Interval Baseline >450
|
0 participants
|
0 participants
|
|
Number of Participants With Out-of Range ECG Evaluations
QTcF Interval Maximum on Treatment ≤ 450
|
30 participants
|
30 participants
|
|
Number of Participants With Out-of Range ECG Evaluations
QTcF Interval Maximum on Treatment > 450
|
0 participants
|
0 participants
|
|
Number of Participants With Out-of Range ECG Evaluations
QTcF Interval Increase from Baseline ≤ 30
|
30 participants
|
30 participants
|
|
Number of Participants With Out-of Range ECG Evaluations
QTcF Interval Increase from Baseline > 30
|
0 participants
|
0 participants
|
Adverse Events
Treatment A
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A
n=30 participants at risk
Apixaban tablets 5 × 0.5-mg
|
Treatment B
n=30 participants at risk
Apixaban sprinkle capsules (treatment B)
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.7%
2/30 • 40 days (1st dose to 30 days after study completion)
|
0.00%
0/30 • 40 days (1st dose to 30 days after study completion)
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60