A Phase I, Multiple Dose Study of PF-04447943 in Healthy Elderly Volunteers

February 23, 2009 updated by: Pfizer

An Investigator And Subject-Blind, Phase 1 Study To Characterize The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Doses Of PF-04447943 In Healthy Elderly Subjects

To describe the safety, tolerability and pharmacokinetics of PF-04447943 after administration of multiple, ascending, oral doses to healthy elderly subjects.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Additional Study Purpose Details: Phase I safety and pharmacokinetics study.

Detailed Description:

The study was terminated on 11/12/2008. There were no safety findings in this trial that resulted in the decision to terminate the trial. The study was closed in order to change the amount of drug that subjects would take and to shorten the number of days that the drug would be taken in a new study.

Study Type

Interventional

Enrollment (Actual)

10

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
      • Gainesville, Florida, United States, 32608
        • 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

Exclusion Criteria:

  • Evidence or history of clinically significant unstable disease

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 14 days
Experimental: PF-04447943 05 mg dose
Drug: PF-04447943
05 mg BID for 14 days
Drug: PF-04447943
15 mg BID for 14 days
Drug: PF-04447943
45mg BID for 14 days
Experimental: PF-04447943 15 mg dose
Drug: PF-04447943
05 mg BID for 14 days
Drug: PF-04447943
15 mg BID for 14 days
Drug: PF-04447943
45mg BID for 14 days
Experimental: PF-04447943 45 mg dose
Drug: PF-04447943
05 mg BID for 14 days
Drug: PF-04447943
15 mg BID for 14 days
Drug: PF-04447943
45mg BID for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary Safety: Adverse events, change from baseline in vital signs, triplicate ECG, clinical safety laboratory endpoints
Time Frame: 14 days
14 days
Pharmacokinetic endpoints will include plasma PF 04447943 AUCt, Cmax and Tmax
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in cognition from baseline
Time Frame: 14 days
14 days

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

August 1, 2008

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

August 15, 2008

First Submitted That Met QC Criteria

August 15, 2008

First Posted (Estimate)

August 18, 2008

Study Record Updates

Last Update Posted (Estimate)

February 25, 2009

Last Update Submitted That Met QC Criteria

February 23, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B0401002

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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