- For Group 1 specific: Healthy male and/or female subjects of non-childbearing
potential between the ages of 18 and 55 years, inclusive at Screening. 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.
- For Group 2 specific: Male and/or female subjects of non-childbearing potential
between the ages of 56 and 75 years, inclusive at Screening. Subjects must be in
reasonably good health as determined by the Investigator based on a detailed medical
history, full physical examination (including blood pressure and pulse rate
measurement), 12-lead ECG and clinical laboratory tests. Subjects with mild, chronic,
stable disease (eg, osteoarthritis) may be enrolled if deemed medically prudent by the
Investigator. At least 50% of the subjects enrolled in these cohorts must be 60 years
of age and above at Screening.
- For Group 2 specific: Subjects taking daily prescription or non-prescription
medications for management of acceptable chronic medical conditions must be on a
stable dose of these, as defined by non change in dose for the 3 months prior to the
first dose of study medication and no planned changes during the conduct of the study.
- For Group 1 specific: 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).
- For Group 2 specific : Evidence or history of unstable disease or moderate to severe
conditions which would, in the Investigator's opinion, interfere with the study
evaluations or impact on the safety of participating subjects, such as orthostatic
- Subjects with history of sleep apnea
- Any condition possibly affecting drug absorption (eg, gastrectomy).