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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy; Non-Smoking

Treatments: Drug: Placebo; Drug: varenicline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00694044

A3051106

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 65 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

50 participants in 4 patient groups, including a placebo group

Weekly titration

Active Comparator group

Treatment:

Drug: varenicline

Drug: varenicline

Drug: varenicline

Two Week QD

Active Comparator group

Treatment:

Drug: varenicline

Drug: varenicline

Drug: varenicline

Two Week BID

Active Comparator group

Treatment:

Drug: varenicline

Drug: varenicline

Drug: varenicline

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo