- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive
(healthy is defined as no clinically relevant abnormalities identified by a detailed
medical history, full physical examination, including blood pressure and pulse rate
measurement, 12-lead ECG and clinical laboratory tests) with a Body Mass Index (BMI)
of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs.) and with a personally
signed and dated informed consent document and who are willing and able to comply with
scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Participating female subjects of non-childbearing potential must meet at least one of
the following criteria: achieved postmenopausal status; have undergone a documented
hysterectomy and/or bilateral oophorectomy; have medically confirmed ovarian failure.
All other female subjects (including females with tubal ligations and females that do
NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure)
will be considered to be of childbearing potential.
- Subjects cannot be included in the study if there is: the presence/ history of any
disorder that prevents study completion
- Evidence/history of clinically significant hematological, renal, endocrine, pulmonary,
gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic
- Any surgical or medical condition that may interfere with the absorption distribution,
metabolism, or excretion of the study drug
- A positive urine drug screen or history of regular excessive alcohol consumption or
use of tobacco-or nicotine-containing products in excess or from 24-hours prior to
admission until discharge
- Treatment with an investigational drug within 30 days (or as determined by the local
requirement) or 5 halflives preceding the first dose of study med.
- Out of range blood pressure including current evidence of orthostatic change in blood
- Abnormal ECG or history or current evidence of clinically important cardiac conduction
- Also excluded are: pregnant or breastfeeding female subjects; male subjects with
partners currently pregnant; male and female subjects of childbearing potential who
are unwilling or unable to use a highly effective method of contraception as described
in the protocol for the duration of the study and for at least 28 days after the last
dose of investigational product.