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

NCT00694044 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2009-06-02

No results posted yet for this study

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.

Conditions

  • Healthy
  • Non-Smoking

Interventions

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

DRUG

varenicline

0.5 mg once daily for 14 days followed by 1 mg once daily for 7 days

DRUG

varenicline

0.5 mg once daily for 14 days followed by 0.5 mg twice daily for 7 days

DRUG

Placebo

Placebo for 21 days

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00694044 on ClinicalTrials.gov