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

NCT00694044

Last updated date
Study Location
Pfizer Investigational Site
Miami, Florida, 33169, United States
Contact
1-800-718-1021

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

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Healthy, Non-SmokingEvaluation of Varenicline Safety, Tolerability, Pharmacokinetics and Pro-Cognitive Effects in Healthy Elderly Non-Smoking Subjects
NCT00694044
  1. Miami, Florida
  2. Orlando, Florida
ALL GENDERS
65 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluation of Varenicline Safety, Tolerability, Pharmacokinetics and Pro-Cognitive Effects in Healthy Elderly Non-Smoking Subjects
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE
  • Healthy
  • Non-Smoking
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2008)
50
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2008)
44
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 65 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00694044
Other Study ID Numbers  ICMJE A3051106
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP