| Eligibility |
Inclusion Criteria:
- Be a male or female between ages 18-65 (inclusive) at the screening visit
- May have a history of pharmacologically well-controlled hypertension or non-insulin
dependent diabetes
- Have a body mass index (BMI) = 19 and = 33 (inclusive)
- BMI = (weight (kg))/(height (m2))
- Have a history of pancreaticoduodenectomy
- If female, subject can be of childbearing potential and must demonstrate a urine ß-hCG
level consistent with the non-gravid state at the screening visit and agree to use
(and/or have their partner use) an acceptable method of birth control beginning at the
screening visit throughout the trial (including washout intervals between treatment
periods) and until 2 weeks after the last dose of trial drug in the last treatment
period. Acceptable methods of birth control: intrauterine device ("IUD" with or
without local hormone release, oral contraceptive pills, diaphragm, cervical cap,
spermicides, contraceptive sponge, and /or condoms). Abstinence is an alternative life
style and subjects practicing abstinence may be included in the trial.
- Can be of non-childbearing potential which is defined as: a female who is
postmenopausal without menses for at least 1 year and an FSH value in the
postmenopausal range upon screening evaluation and/or a female who is status post
hysterectomy, oophorectomy or tubal ligation.
- Have serum creatinine level < 1.5 mg/dL
- Have a prothrombin time (PT) and activated partial thromboplastin time (PTT) level
below the upper limit of normal
- Have platelet count within normal limits
- Be willing to refrain from the use of anticoagulants and antiplatelet medications
including aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) during the entire
period of study participation
- Be willing to comply with trial restrictions
Exclusion Criteria:
The subject will be excluded from participating in the trial if the subject:
- Has a history of clinically significant medical condition that based upon the judgment
of the investigator makes participation inappropriate
- Has a history of a major bleeding event (defined as: (i) symptomatic bleeding in a
critical area or organ, such as intracranial, intraspinal, intraocular,
retroperitoneal, intra-articular or pericardial, or intramuscular with compartment
syndrome, and/or (ii) a fall in hemoglobin level of 2 g/dL or more, or leading to
transfusion of two or more units of whole blood or red cells) within 6 months prior to
screening visit
- Has had major surgery within 6 months prior to screening visit
- Is actively taking any the following list of medications/supplements and cannot hold
these medications for <5 half-lives prior to the study:
- CYP3A4 Moderate/Strong Inhibitors:
Selective Serotonin Reuptake Inhibitors (SSRI) Amiodarone, Dronedarone Diltiazem Cimetidine
Aprepitant Protease Inhibitors CYP3A4 Inducers Rifampin Phenytoin Carbemazepine Ritonavir
St. John's Wort Enzalutamide Efavirenz Teriflunomide Bosentan Modafinil Mitotane Other
Pancreatic Enzyme Replacement (Creon, Pancrelipase, Viokase)
- Has a history of illicit drug abuse within six months prior to screening visit
- Is an active smoker (last exposure <2 weeks prior to study screening)
- Pregnant or lactating
- Consumes greater than 3 glasses of alcoholic beverages (1 glass is approximately
equivalent to: beer [354 mL/12 ounces], wine [118 mL/4 ounces], or distilled spirits
[29.5 mL/1 ounce]) per day and cannot refrain from alcohol for the duration of the
trial
- Has a history of significant multiple and/or severe allergies (e.g. food, drug), or
has had an anaphylactic reaction or significant intolerability to prescription or
non-prescription drugs or food
- Has known anaphylactic or severe systemic reactions to any components of apixaban or
contraindication to the administration of apixaban
- Has moderate or severe hepatic disease or other clinically relevant bleeding risk
- Use of any drugs or products which at the discretion of the investigator would
increase bleeding risk
- Is considered inappropriate for participation by the investigator for any reason
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