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

June 1, 2009 updated by: Pfizer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo for 21 days
Active Comparator: Weekly titration
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 Names:
  • Champix, Chantix
Drug: varenicline
0.5 mg once daily for 14 days followed by 1 mg once daily for 7 days
Other Names:
  • Champix, Chantix
Drug: varenicline
0.5 mg once daily for 14 days followed by 0.5 mg twice daily for 7 days
Other Names:
  • Champix, Chantix
Active Comparator: Two Week QD
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 Names:
  • Champix, Chantix
Drug: varenicline
0.5 mg once daily for 14 days followed by 1 mg once daily for 7 days
Other Names:
  • Champix, Chantix
Drug: varenicline
0.5 mg once daily for 14 days followed by 0.5 mg twice daily for 7 days
Other Names:
  • Champix, Chantix
Active Comparator: Two Week BID
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 Names:
  • Champix, Chantix
Drug: varenicline
0.5 mg once daily for 14 days followed by 1 mg once daily for 7 days
Other Names:
  • Champix, Chantix
Drug: varenicline
0.5 mg once daily for 14 days followed by 0.5 mg twice daily for 7 days
Other Names:
  • Champix, Chantix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tolerability and safety (adverse events, electrocardiogram, vital signs, clinical safety labs, self reported nausea visual analogue scales)
Time Frame: 21 days
21 days
Steady state pharmacokinetics
Time Frame: 21 days
21 days
Effects on cognition (computerized battery of cognitive tests)
Time Frame: 21 days
21 days

Secondary Outcome Measures

Outcome Measure
Time Frame
No secondary outcomes.
Time Frame: Time frame n/a
Time frame n/a

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

June 5, 2008

First Submitted That Met QC Criteria

June 6, 2008

First Posted (Estimate)

June 10, 2008

Study Record Updates

Last Update Posted (Estimate)

June 2, 2009

Last Update Submitted That Met QC Criteria

June 1, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3051106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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