Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apixaban sprinkle capsules followed by apixaban tablets | Experimental | Apixaban (BMS-562247) sprinkle capsules followed by apixaban tablets |
|
| Apixaban tablets followed by apixaban sprinkle capsules | Active Comparator | Apixaban (BMS-562247) tablets followed by apixaban sprinkle capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: Apixaban sprinkle capsules | Drug | Single dose (25 x 0.1 mg capsules), oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | Day 1 to Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 1 to Day 8 |
| T-Half - Terminal Plasma Half Life. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Development, LP | Austin | Texas | 78744 | United States |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
Not provided
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
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment A, Then Treatment B | Apixaban tablets (treatment A) followed by apixaban sprinkle capsules (treatment B) |
| FG001 | Treatment B, Then Treatment A | Apixaban sprinkle capsules (treatment B) followed by apixaban tablets (treatment A) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Initial Treatment |
| |||||||||||||
| Initial Treatment Washout |
| |||||||||||||
| Cross-over and Treatment |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment A | Apixaban tablets (treatment A) followed by apixaban sprinkle capsules (treatment B) |
| BG001 | Treatment B | Apixaban sprinkle capsules (treatment B) followed by apixaban tablets (treatment A) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | All Treated Participants | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1 to Day 8 |
|
40 days (1st dose to 30 days after study completion)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A | Apixaban tablets 5 × 0.5-mg | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 21.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please Email | Clinical.Trials@bms.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 21, 2018 | Jun 14, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 4, 2018 | Jun 14, 2019 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C522181 | apixaban |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Experimental: Apixaban tablets followed by apixaban sprinkle capsules | Drug | Apixaban sprinkle capsules Single dose (25 x 0.1 mg capsules), oral administration |
|
|
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
| Day 1 to Day 8 |
| Frel - Relative Bioavailability | The relative bioavailability of 0.1mg apixaban sprinkle capsules as compared to 0.5mg tablet formulation | Day 1 to Day 8 |
| Number of Participants With Adverse Events Regardless of Causality, Serious Adverse Events and Adverse Events Leading to Discontinuation | Adverse events regardless of causality, Serious Adverse Events & Adverse events leading to discontinuation | Day 1 to Day 38 |
| Physical Measurement - Height | Average height of all participants treated | Pre-treatment Screening |
| Physical Measurement - Weight | Average weight of all participants treated | 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. | Pre-treatment Screening to Day 8 |
| Number of Participants With a Given Clinical Laboratory Abnormality | Assessment of clinical laboratory abnormalities | 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 | 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 | 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 | 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 | 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) | Day 1 to Day 8 |
| FDA Safety Alerts and Recalls | View source |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | 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 | All Treated Participants | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Day 1 to Day 8 |
|
|
|
| Primary | 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 | All Treated Participants | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Day 1 to Day 8 |
|
|
|
| Secondary | 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 | All Treated Participants | Posted | Geometric Mean | Geometric Coefficient of Variation | h (hours) | Day 1 to Day 8 |
|
|
|
| Secondary | 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 | All Treated Participants | Posted | Geometric Mean | Geometric Coefficient of Variation | h (hours) | Day 1 to Day 8 |
|
|
|
| Secondary | Frel - Relative Bioavailability | The relative bioavailability of 0.1mg apixaban sprinkle capsules as compared to 0.5mg tablet formulation | All Treated Participants | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage | Day 1 to Day 8 |
|
|
|
| Secondary | Number of Participants With Adverse Events Regardless of Causality, Serious Adverse Events and Adverse Events Leading to Discontinuation | Adverse events regardless of causality, Serious Adverse Events & Adverse events leading to discontinuation | All Treated Participants | Posted | Number | Participants | Day 1 to Day 38 |
|
|
|
| Secondary | Physical Measurement - Height | Average height of all participants treated | All treated participants | Posted | Mean | Standard Deviation | centimeter (cm) | Pre-treatment Screening |
|
|
|
| Secondary | Physical Measurement - Weight | Average weight of all participants treated | All treated participants | Posted | Mean | Standard Deviation | kilograms (kg) | Pre-treatment screening to Day 8 |
|
|
|
| Secondary | 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. | All treated participants | Posted | Mean | Standard Deviation | kilograms / Meters² (kg/m²) | Pre-treatment Screening to Day 8 |
|
|
|
| Secondary | Number of Participants With a Given Clinical Laboratory Abnormality | Assessment of clinical laboratory abnormalities | All Treated Participants | Posted | Number | participants | Day 1 to Day 8 |
|
|
|
| Secondary | 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 | All treated participants | Posted | Number | participants | Day 1 to Day 8 |
|
|
|
| Secondary | 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 | All treated participants | Posted | Number | participants | Day 1 to Day 8 |
|
|
|
| Secondary | 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 | All treated participants | Posted | Number | participants | Day 1 to Day 8 |
|
|
|
| Secondary | 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 | All treated participants | Posted | Number | participants | Day 1 to Day 8 |
|
|
|
| Secondary | 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) | All treated participants | Posted | Number | participants | Day 1 to Day 8 |
|
|
|
| 30 |
| 0 |
| 30 |
| 2 |
| 30 |
| EG001 | Treatment B | Apixaban sprinkle capsules (treatment B) | 0 | 30 | 0 | 30 | 0 | 30 |
Not provided
| Adverse Events leading to Discontinuation |
|
| Day 8 |
|
| Day 8 |
|
| Hematocrit abnormal low |
|
|
| Platelet count abnormal low |
|
|
| platelet count abnormal high |
|
|
| Leukocytes abnormal low |
|
|
| Leukocytes Abnormal high |
|
|
| Neutrophils (Absolute) Abnormal low |
|
|
| Lymphocytes abnormal low |
|
|
| Lymphocytes Abnormal high |
|
|
| Monocytes (Absolute) Abnormal High |
|
|
| Basophils (absolute) Abnormal High |
|
|
| Eosinophils (absolute) Abnormal High |
|
|
| Prothrombin Time (PT) Abnormal High |
|
|
| International Normalized Ratio (INR) Abnormal High |
|
|
| Alkaline Phosphate (ALP) Abnormal High |
|
|
| Aspartate Aminotransferase (AST) Abnormal High |
|
|
| Alanine Aminotransferase (ALT) Abnormal High |
|
|
| Bilirubin, Total Abnormal High |
|
|
| Blood Urea Nitrogen (BUN) Abnormal High |
|
|
| Creatinine Abnormal High |
|
|
| Sodium Abnormal Low |
|
|
| Sodium, Serum Abnormal High |
|
|
| Potassium Abnormal Low |
|
|
| Potassium, Serum Abnormal High |
|
|
| Chloride, Serum Abnormal Low |
|
|
| Chloride, Serum Abnormal High |
|
|
| Calcium, Serum Abnormal Low |
|
|
| Calcium, Serum Abnormal High |
|
|
| Phosphorus, Inorganic Abnormal Low |
|
|
| Phosphorus, Inorganic Abnormal High |
|
|
| Glucose, Fasting Serum Abnormal Low |
|
|
| Glucose, Fasting Serum Abnormal High |
|
|
| Protein, Total Abnormal Low |
|
|
| Protein, Total Abnormal High |
|
|
| Albumin Abnormal Low |
|
|
| Lactate Dehydrogenase (LDH) Abnormal High |
|
|
| Protein, Urine Abnormal High |
|
|
| Glucose, Urine Abnormal High |
|
|
| Blood, Urine Abnormal High |
|
|
| WBC, Urine Abnormal High |
|
|
| RBC, Urine Abnormal High |
|
|
| DBP < 55 and change from baseline < -10 |
|
| DBP >90 and change from baseline >10 |
|
| >16 or change from baseline >10 rpm |
|
| >38.3°C or change from baseline > 1.6°C |
|
| PR Interval Maximum on Treatment ≤ 200 |
|
| PR Interval Maximum on Treatment >200 |
|
| QRS Interval Baseline ≤ 120 |
|
| QRS Interval Baseline >200 |
|
| QRS Interval Maximum on Treatment ≤ 120 |
|
| QRS Interval Maximum on Treatment > 120 |
|
| QT Interval Baseline ≤ 500 |
|
| QT Interval Baseline >500 |
|
| QT Interval Maximum on Treatment ≤ 500 |
|
| QT Interval Maximum on Treatment > 500 |
|
| QT Interval Increase from Baseline ≤ 30 |
|
| QT Interval Increase from Baseline > 30 |
|
| QTcF Interval Baseline ≤ 450 |
|
| QTcF Interval Baseline >450 |
|
| QTcF Interval Maximum on Treatment ≤ 450 |
|
| QTcF Interval Maximum on Treatment > 450 |
|
| QTcF Interval Increase from Baseline ≤ 30 |
|
| QTcF Interval Increase from Baseline > 30 |
|