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Completed

NCT Number: NCT03509883

Bioavailability of Apixaban Sprinkle Compared to Apixaban Capsules

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Development, LP

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Drug: Apixaban sprinkle capsules

Drug

Single dose (25 x 0.1 mg capsules), oral administration

Other names: •BMS-562247, •Eliquis

Experimental: Apixaban tablets followed by apixaban sprinkle capsules

Drug

Apixaban sprinkle capsules Single dose (25 x 0.1 mg capsules), oral administration

Other names: •BMS-562247

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Physical Measurement - Height

    Time frame: Pre-treatment Screening

    Average height of all participants treated

  6. Physical Measurement - Weight

    Time frame: Pre-treatment screening to Day 8

    Average weight of all participants treated

  7. 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.

  8. Number of Participants With a Given Clinical Laboratory Abnormality

    Time frame: Day 1 to Day 8

    Assessment of clinical laboratory abnormalities

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 26, 2018
Registry last updated
Jan 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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