- Healthy male and/or female subjects of non-childbearing potential 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).
Female subjects of non-childbearing potential must meet at least one of the following
criteria:
1. Achieved postmenopausal status, defined as follows: cessation of regular menses for at
least 12 consecutive months with no alternative pathological or physiological cause;
and have a serum follicle-stimulating hormone (FSH) level confirming the
post-menopausal state;
2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
3. 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.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110
lbs).
- Evidence of a personally signed and dated informed consent document indicating
that the subject has been informed of all pertinent aspects of the study.
- Subjects who are willing and able to comply with scheduled visits, treatment
plan, laboratory tests, and other study procedures.
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).
- Treatment with an investigational drug within 30 days (or as determined by the local
requirement) or 5 half-lives preceding the first dose of study medication (whichever
is longer).
- Screening supine blood pressure >= 140 mm Hg (systolic) or >=90 mm Hg (diastolic),
following at least 5 minutes of rest. If BP is >=140 mm Hg (systolic) or >=90 mm Hg
(diastolic), repeat per local standard operating procedures (SOP). If orthostatic
changes are present and deemed to be clinically significant by the investigator,
Subject can be excluded.
- For subjects who answer "Yes" to the Columbia Suicide Severity Rating Scale (C-SSRS)
questions 4 or 5, a risk assessment should be done by a qualified mental health
professional (MHP: a psychiatrist or licensed PhD level clinical psychologist) to
assess whether it is safe for the subject to participate in the study. In addition,
subjects deemed by the investigator to be at significant risk of suicidal or violent
behavior should be excluded.