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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Miami, Florida, 33169 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy, Non-Smoking
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65-85 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

Creatinine Clearnace diseases

NCT00694044
Pfizer
Completed
Evaluation of Varenicline Safety, Tolerability, Pharmacokinetics and Pro-Cognitive Effects in Healthy Elderly Non-Smoking Subjects

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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
  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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
  • Healthy
  • Non-Smoking
  • 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
    Other Name: Champix, Chantix
  • Drug: varenicline
    0.5 mg once daily for 14 days followed by 1 mg once daily for 7 days
    Other Name: Champix, Chantix
  • Drug: varenicline
    0.5 mg once daily for 14 days followed by 0.5 mg twice daily for 7 days
    Other Name: Champix, Chantix
  • Drug: Placebo
    Placebo for 21 days
  • Active Comparator: Weekly titration
    Intervention: Drug: varenicline
  • Active Comparator: Two Week QD
    Intervention: Drug: varenicline
  • Active Comparator: Two Week BID
    Intervention: Drug: varenicline
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2008
June 2008   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
65 Years to 85 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00694044
A3051106
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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