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CompletedNCT00694044Updated Jun 2, 2009

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

A Phase 1 interventional study of varenicline and varenicline in Healthy and Non-Smoking, sponsored by Pfizer. Completed at 2 sites in United States. Open to participants aged 65 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-06-02.

Sponsored by Pfizer · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
65 Years to 85 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Healthy
  • Non-Smoking

Keywords

  • Safety, Tolerability, Pharmacokinetics, Cognition
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Healthy, Elderly (65-85 years inclusive), Non-smoker

Exclusion criteria

Exclusion Criteria:

Creatinine Clearnace \< 30 ml/min, Evidence or history of clinically significant, unstable diseases

05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    Weekly titration

    Drug: varenicline

  • Active comparator
    Two Week QD

    Drug: varenicline

  • Active comparator
    Two Week BID

    Drug: varenicline

  • Placebo comparator
    Placebo

    Drug: Placebo

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

    Also known as: Champix, Chantix

  • Drugvarenicline

    0.5 mg once daily for 14 days followed by 1 mg once daily for 7 days

    Also known as: Champix, Chantix

  • Drugvarenicline

    0.5 mg once daily for 14 days followed by 0.5 mg twice daily for 7 days

    Also known as: Champix, Chantix

  • DrugPlacebo

    Placebo for 21 days

06

What researchers measure

Primary outcomes

  1. Tolerability and safety (adverse events, electrocardiogram, vital signs, clinical safety labs, self reported nausea visual analogue scales)

    Time frame: 21 days

  2. Steady state pharmacokinetics

    Time frame: 21 days

  3. Effects on cognition (computerized battery of cognitive tests)

    Time frame: 21 days

Secondary outcomes

  1. No secondary outcomes.

    Time frame: Time frame n/a

07

Study locations

2 sites
  • Pfizer Investigational Site
    Miami, Florida 33169, United States
  • Pfizer Investigational Site
    Orlando, Florida 32809, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00694044
Lead sponsor
Pfizer
First posted
Jun 10, 2008
Start date
Apr 2008
Primary completion
Jun 2008
Completion
Jun 2008
Last update
Jun 2, 2009

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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