- Healthy male and/or female subjects between the ages of 65 and 85 years, inclusive.
Ideally at least 25% of the subjects enrolled in each cohort will be 75 years of age
and above at Screening. Subjects must be healthy 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 test
results. Subjects with mild, chronic, stable disease and on stable medication may be
enrolled if deemed medically prudent by the investigator.
- 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 (or a legally acceptable representative) has been informed of all
pertinent aspects of the study.
- 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).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- Evidence of gout/hyperuricemia, measured sUA >8 mg/dL at screening.
- Experienced an episode of nephrolithiasis or ureterolithiasis.