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NCT00694044 Clinical Trial

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

Healthy Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00694044
Other study ID # A3051106
Secondary ID
Status Completed
Phase Phase 1
First received June 5, 2008
Last updated June 1, 2009
Start date April 2008
Est. completion date June 2008

Study information
Verified date June 2009
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years to 85 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

Intervention

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
• varenicline
0.5 mg once daily for 14 days followed by 1 mg once daily for 7 days
• varenicline
0.5 mg once daily for 14 days followed by 0.5 mg twice daily for 7 days
• Placebo
Placebo for 21 days

Locations
Country Name City State
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Orlando Florida

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tolerability and safety (adverse events, electrocardiogram, vital signs, clinical safety labs, self reported nausea visual analogue scales) 21 days Yes
Primary Steady state pharmacokinetics 21 days No
Primary Effects on cognition (computerized battery of cognitive tests) 21 days No
Secondary No secondary outcomes. Time frame n/a No
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