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
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 April 17, 2014