Bioavailability of Apixaban Sprinkle Compared to Apixaban Capsules
Condition: Healthy Volunteers
Intervention: Drug: Apixaban sprinkle capsules; Experimental: Apixaban tablets followed by apixaban sprinkle capsules
Intervention description: Single dose (25 x 0.1 mg capsules), oral administration; Apixaban sprinkle capsules Single dose (25 x 0.1 mg capsules), oral administration
Intervention MeSH terms: Apixaban
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 94.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        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.