NCT00694044

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

A Randomized, Investigator and Subject Blind, Sponsor Open Parallel Group Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pro-Cognitive Effects of Varenicline, Under Various Titration Schemes, in Healthy Elderly Non-Smoking Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy
• Non-Smoking

Interventions

Type	Name	Description
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
DRUG	varenicline	0.5 mg once daily for 14 days followed by 1 mg once daily for 7 days
DRUG	varenicline	0.5 mg once daily for 14 days followed by 0.5 mg twice daily for 7 days
DRUG	Placebo	Placebo for 21 days

Timeline

• Start date: 2008-04-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2008-06-10
• Last updated: 2009-06-02

Locations

2 sites across 1 country: United States