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

Phase 1

Completed

• Conditions: Healthy; Non-Smoking
• Interventions: Drug: varenicline; Drug: Placebo

• Registration Number: NCT00694044
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Study First Submitted: 2008-06-05
• Study First Submitted QC: 2008-06-06
• Study First Posted: 2008-06-10
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-01
• Last Update Posted: 2009-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weekly titration	varenicline	-
Two Week QD	varenicline	-
Two Week BID	varenicline	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Tolerability and safety (adverse events, electrocardiogram, vital signs, clinical safety labs, self reported nausea visual analogue scales)	21 days
Steady state pharmacokinetics	21 days
Effects on cognition (computerized battery of cognitive tests)	21 days

Secondary Outcome Measures

Name	Time	Method
No secondary outcomes.	Time frame n/a

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Orlando, Florida, United States