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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00694044

Enrollment

Registered

2008-06-10

Start date

2008-04-30

Completion date

2008-06-30

Last updated

2009-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Non-Smoking

Keywords

Safety, Tolerability, Pharmacokinetics, Cognition

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.

Interventions

DRUGvarenicline

0.5 mg once daily for 7days followed by 0.5 mg twice daily for 7days followed by 1mg twice daily for 7 days

DRUGPlacebo

Placebo for 21 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

65 Years to 85 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
No secondary outcomes.	Time frame n/a

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026