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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The purpose of this study is to assess the bioavailability of Apixaban oral solution administered through an Nasogastric Tube (NGT) in the presence of Boost® Plus and Apixaban administered as crushed tablet through a nasogastric tube relative to Apixaban solution administered orally in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A-Apixaban | Experimental | Solution Apixaban 5 mg ( 0.4 mg/ml oral solution x 12.5 ml) through mouth or oral syringe |
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| Arm B-Apixaban | Experimental | 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 |
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| Arm C-Apixaban | Experimental | Single dose crushed Apixaban tablet 5 mg (5 mg tablet crushed and suspended in 60 mL Dextrose 5% in water (D5W)) through NGT |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban | Drug |
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| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention |
| 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) | Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention |
| 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) | Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention |
| Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Apixaban |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Healthcare Discoveries, LLC D/B/A Icon Development Solutions | San Antonio | Texas | 78209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26188837 | Derived | Song Y, Wang X, Perlstein I, Wang J, Badawy S, Frost C, LaCreta F. Relative Bioavailability of Apixaban Solution or Crushed Tablet Formulations Administered by Mouth or Nasogastric Tube in Healthy Subjects. Clin Ther. 2015 Aug;37(8):1703-12. doi: 10.1016/j.clinthera.2015.05.497. Epub 2015 Jul 15. |
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37 participants were enrolled; 21 were randomized and treated. Reasons for non-randomization include 11 no longer met study criteria, 1 withdrew consent and 4 for other, not specified reasons. 20 participants completed the study; 1 withdrew consent on day 4 of treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment A, Then Treatment B, Then Treatment C | Each participant was given three interventions, one per period, with a 4 day washout in between periods Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Boost Plus |
| Dietary Supplement |
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AUC(INF) is measured in nanogram hours per milliliter (ng*h/mL) |
| Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention |
| 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) | Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention |
| 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 | Day 1 to 30 days after last dose of study drug |
| 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 | Day 1 to 30 days after last dose of study drug |
| FG001 | Treatment A, Then Treatment C, Then Treatment B | Each participant was given three interventions, one per period, with a 4 day washout in between periods Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT |
| FG002 | Treatment B, Then Treatment A, Then Treatment C | Each participant was given three interventions, one per period, with a 4 day washout in between periods Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT |
| FG003 | Treatment B, Then Treatment C, Then Treatment A | Each participant was given three interventions, one per period, with a 4 day washout in between periods Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT |
| FG004 | Treatment C, Then Treatment A, Then Treatment B | Each participant was given three interventions, one per period, with a 4 day washout in between periods Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT |
| FG005 | Treatment C, Then Treatment B, Then Treatment A | Each participant was given three interventions, one per period, with a 4 day washout in between periods Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT |
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| NOT COMPLETED |
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All randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | All Treatment Groups | All Randomized Participants |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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) | All randomized participants with available pharmacokinetic (PK) data | Posted | Geometric Mean | 90% Confidence Interval | ng/mL | Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention |
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| Primary | 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) | All randomized participants with available PK data | Posted | Geometric Mean | 90% Confidence Interval | ng*h/mL | Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention |
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| Primary | 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) | All randomized participants with available PK data | Posted | Geometric Mean | 90% Confidence Interval | ng*h/mL | Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention |
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| Secondary | 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) | All randomized participants with available PK data | Posted | Geometric Mean | 90% Confidence Interval | ng/mL | Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention |
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| Secondary | 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) | All randomized participants with available PK data | Posted | Geometric Mean | 90% Confidence Interval | ng*h/mL | Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention |
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| Secondary | 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) | All randomized participants with available PK data | Posted | Geometric Mean | 90% Confidence Interval | ng*h/mL | Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention |
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| Secondary | 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 | All randomized participants | Posted | Number | participants | Day 1 to 30 days after last dose of study drug |
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| Secondary | 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 | All randomized participants | Posted | Number | participants | Day 1 to 30 days after last dose of study drug |
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Day 1 to 30 days after last dose of study drug
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| 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 | Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe | 0 | 20 | 6 | 20 | ||
| EG001 | Treatment B | Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT | 0 | 20 | 3 | 20 | ||
| EG002 | Treatment C | Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT | 1 | 21 | 1 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastritis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematoma | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
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| Pyuria | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 14.1 | Systematic Assessment |
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| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
| ID | Term |
|---|---|
| C522181 | apixaban |
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| OG002 | Treatment C | Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT |
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| Participants |
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