Evaluation of Varenicline Safety, Tolerability, Pharmacokinetics and Pro-Cognitive Effects in Healthy Elderly Non-Smoking Subjects

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.

• Healthy
• Non-Smoking

• Drug: varenicline
  
  0.5 mg once daily for 7days followed by 0.5 mg twice daily for 7days followed by 1mg twice daily for 7 days
  Other Name: Champix, Chantix
• Drug: varenicline
  
  0.5 mg once daily for 14 days followed by 1 mg once daily for 7 days
  Other Name: Champix, Chantix
• Drug: varenicline
  
  0.5 mg once daily for 14 days followed by 0.5 mg twice daily for 7 days
  Other Name: Champix, Chantix
• Drug: Placebo
  
  Placebo for 21 days

• Active Comparator: Weekly titration
  
  Intervention: Drug: varenicline
• Active Comparator: Two Week QD
  
  Intervention: Drug: varenicline
• Active Comparator: Two Week BID
  
  Intervention: Drug: varenicline
• Placebo Comparator: Placebo
  
  Intervention: Drug: Placebo

Inclusion Criteria:

Healthy, Elderly (65-85 years inclusive), Non-smoker

Exclusion Criteria:

Creatinine Clearnace < 30 ml/min, Evidence or history of clinically significant, unstable diseases