Bioavailability of Apixaban Sprinkle Compared to Apixaban Capsules

January 13, 2020 updated by: Bristol-Myers Squibb

A Study to Assess the Absorption of Apixaban (BMS-562247) Sprinkle Capsules Compared With Tablets in Healthy Volunteers

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
94

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78744
        • PPD Development, LP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Concentration as Measured by Maximum Observed Plasma Concentration (Cmax)
Time Frame: Day 1 to Day 8
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
Time Frame: 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
Day 1 to Day 8
AUC (INF) - Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time
Time Frame: 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
Day 1 to Day 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tmax - Time of Maximum Observed Plasma Concentration
Time Frame: 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
Day 1 to Day 8
T-Half - Terminal Plasma Half Life.
Time Frame: 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
Day 1 to Day 8
Frel - Relative Bioavailability
Time Frame: Day 1 to Day 8
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
Time Frame: Day 1 to Day 38
Adverse events regardless of causality, Serious Adverse Events & Adverse events leading to discontinuation
Day 1 to Day 38
Physical Measurement - Height
Time Frame: Pre-treatment Screening
Average height of all participants treated
Pre-treatment Screening
Physical Measurement - Weight
Time Frame: Pre-treatment screening to Day 8
Average weight of all participants treated
Pre-treatment screening to Day 8
Physical Measurement - Body Mass Index (BMI)
Time Frame: 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.
Pre-treatment Screening to Day 8
Number of Participants With a Given Clinical Laboratory Abnormality
Time Frame: Day 1 to Day 8
Assessment of clinical laboratory abnormalities
Day 1 to Day 8
Number of Participants With Out-of Range Vital Signs: Blood Pressure
Time Frame: 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
Day 1 to Day 8
Number of Participants With Out-of Range Vital Signs: Heart Rate (Bpm)
Time Frame: 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
Day 1 to Day 8
Number of Participants With Out-of Range Vital Signs: Respiration Rate
Time Frame: 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
Day 1 to Day 8
Number of Participants With Out-of Range Vital Signs: Temperature
Time Frame: 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
Day 1 to Day 8
Number of Participants With Out-of Range ECG Evaluations
Time Frame: Day 1 to Day 8
Number of participants with out-of-range ECG changes. ECG intervals are measured in milliseconds (msec)
Day 1 to Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 26, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CV185-687

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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