1. Characterize the tolerability and safety of repeated doses of varenicline in healthy non-smoking elderly subjects. 2. Describe the steady state pharmacokinetics of varenicline in healthy non-smoking elderly subjects. 3. Evaluate the potential effects of repeat doses of varenicline on cognition in healtly non-smoking elderly subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
50
0.5 mg once daily for 7days followed by 0.5 mg twice daily for 7days followed by 1mg twice daily for 7 days
0.5 mg once daily for 14 days followed by 1 mg once daily for 7 days
0.5 mg once daily for 14 days followed by 0.5 mg twice daily for 7 days
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Orlando, Florida, United States
Tolerability and safety (adverse events, electrocardiogram, vital signs, clinical safety labs, self reported nausea visual analogue scales)
Time frame: 21 days
Steady state pharmacokinetics
Time frame: 21 days
Effects on cognition (computerized battery of cognitive tests)
Time frame: 21 days
No secondary outcomes.
Time frame: Time frame n/a
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Placebo for 21 days