NCT00694044

Brief Summary

  1. 1.Characterize the tolerability and safety of repeated doses of varenicline in healthy non-smoking elderly subjects.
  2. 2.Describe the steady state pharmacokinetics of varenicline in healthy non-smoking elderly subjects.
  3. 3.Evaluate the potential effects of repeat doses of varenicline on cognition in healtly non-smoking elderly subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2008

Completed
Last Updated

June 2, 2009

Status Verified

June 1, 2009

Enrollment Period

2 months

First QC Date

June 5, 2008

Last Update Submit

June 1, 2009

Conditions

HealthyNon-Smoking

Keywords

Safety, Tolerability, Pharmacokinetics, Cognition

Outcome Measures

Primary Outcomes (3)

  • Tolerability and safety (adverse events, electrocardiogram, vital signs, clinical safety labs, self reported nausea visual analogue scales)

    21 days

  • Steady state pharmacokinetics

    21 days

  • Effects on cognition (computerized battery of cognitive tests)

    21 days

Secondary Outcomes (1)

  • No secondary outcomes.

    Time frame n/a

Study Arms (4)

Weekly titration

ACTIVE COMPARATOR
Drug: varenicline

Two Week QD

ACTIVE COMPARATOR
Drug: varenicline

Two Week BID

ACTIVE COMPARATOR
Drug: varenicline

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

vareniclineDRUG

0.5 mg once daily for 7days followed by 0.5 mg twice daily for 7days followed by 1mg twice daily for 7 days

Also known as: Champix, Chantix
Weekly titration
PlaceboDRUG

Placebo for 21 days

Placebo

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Creatinine Clearnace \< 30 ml/min, Evidence or history of clinically significant, unstable diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pfizer Investigational Site

Miami, Florida, 33169, United States

Location

Pfizer Investigational Site

Orlando, Florida, 32809, United States

Location

Related Links

MeSH Terms

Interventions

Varenicline

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 5, 2008

First Posted

June 10, 2008

Study Start

April 1, 2008

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

June 2, 2009

Record last verified: 2009-06

Locations

US(2)