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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00694044
First received: June 5, 2008
Last updated: June 1, 2009
Last verified: June 2009
  Purpose
  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.

Condition Intervention Phase
Healthy
Non-Smoking
Drug: varenicline
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Tolerability and safety (adverse events, electrocardiogram, vital signs, clinical safety labs, self reported nausea visual analogue scales) [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
  • Steady state pharmacokinetics [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Effects on cognition (computerized battery of cognitive tests) [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • No secondary outcomes. [ Time Frame: Time frame n/a ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: April 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Champix, Chantix
Active Comparator: Two Week QD Drug: varenicline
0.5 mg once daily for 14 days followed by 1 mg once daily for 7 days
Other Name: Champix, Chantix
Active Comparator: Two Week BID Drug: varenicline
0.5 mg once daily for 14 days followed by 0.5 mg twice daily for 7 days
Other Name: Champix, Chantix
Placebo Comparator: Placebo Drug: Placebo
Placebo for 21 days

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694044

Locations
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33169
Pfizer Investigational Site
Orlando, Florida, United States, 32809
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00694044     History of Changes
Other Study ID Numbers: A3051106
Study First Received: June 5, 2008
Last Updated: June 1, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Safety, Tolerability, Pharmacokinetics, Cognition

Additional relevant MeSH terms:
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014